Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities: An 18 month Randomized Clinical Trial

Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities: An 18 month Randomized Clinical Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities: An 18 month Randomized Clinical Trial Basma Reda Abdelhafeez, Heba Helal, Olfat Hasanin, Essam Abdelhafez This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6237005/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Bioactive materials can stop caries progression through releasing fluoride. The challenge in restoring cervical cavities is the dentin in the cervical margin where the high organic content and fluid movement in dentinal tubules make it a complicated structure. This study was carried out to evaluate the clinical performance of two different bioactive injectable flowable resin composite materials in restoring class V cavities over 18 months. Methods Thirty four participants with class V carious lesions were enrolled randomly. The participants were assigned into two groups (n = 17): Group (1) Beautifil Flow Plus X. Group (2) ACTIVA bioactive restorative. The modified USPHS criteria were used to evaluate ehe restorations at baseline as well as after 6, 12 and 18 months. Categorical data was described as frequency and percentage, the Chi-Squared test was used for intragroup comparisons between intervention and comparator while Cochran’s Q test was used for intragroup comparison in each group followed by multiple comparisons. Results There was no statistically significant difference in the intergroup comparisons in all the USBH criteria that was evaluated. Both groups revealed statistically significant differences in surface texture and anatomical form over different follow-up periods. Conclusions Both Beautifil flow plus X and ACTIVA bioactive have acceptable clinical performance in class V cavities after 18 months follow up period. Clinical Significance: Beautifil Flow Plus X injectable composite could be a promising material for restoring cervical cavities. Clinical trial registration: The trial was registered retrospectively on (15/07/2022) at https://clinicaltrials.gov with the ID (NCT05466461). Giomer technology S-PRG Beautifil flow Smart bioactive ACTIVA bioactive Injectable composite Clinical performance Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Introduction Caries was thought to be a progressive condition that needed to be completely removed in order to prepare a cavity. Since caries is now recognized as a disease that may be prevented and reversed, efforts have focused on reducing its occurrence and reversing early lesions through ion precipitation remineralization. Furthermore, selective caries removal approach was made feasible by the potential to remineralize dentin collagen that has been partially demineralized by caries. Nowadays, fully demineralized dentin matrix has been successfully remineralized using recent biomimetic remineralization techniques ( 1 ) . There are several materials available to restore class V cavities, including glass ionomer cement (GIC), resin modified GIC, and composite resin. Although composite resin is the most popular one because of its aesthetic strength, polymerization shrinkage which is the main drawback of composite that is the main cause of marginal gap and leakage. The term "smart materials" refers to the relatively new concept of bioactive restorative materials, which are stated to have more fluoride release than glass ionomers and react to PH changes in the oral cavity by absorbing calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure. These materials can be controlled by a variety of stimuli, including pH, moisture, temperature and stress, and they can return to their original state after removal of the stimulus. One such material is ACTIVA Bioactive restorative (Pulpdent, USA), which is made up of a patented bioactive shock-absorbing rubberized ionic-resin (Embrace resin) matrix with a small amount of water. It has no Bisphenol A, Bis-GMA or BPA monomer ( 2 ) . Another example of smart hybrid materials is Giomer which was introduced in 2000. It includes a stable glass–ionomer phase on a glass core, which initiates an acid-base reaction between fluoride-containing glass and polycarboxylic acid in the presence of water, forming pre-reacted glass-ionomer (PRG) filler ( 3 ) . There are two types of Pre-Reacted Glass-ionomer (PRG) Filler. Full reaction type (FPRG) where the entire glass filler reacted with polycarboxylic acid and surface reaction type (SPRG) in which the surface of the glass filler reacted with poly acids ( 4 ), ( 5 ) . S-PRGs are inorganic bioactive fillers with the added capability of ion release. Because S-PRG filler may release a variety of ions, including Al, B, F, Na, Si, and Sr, it is regarded as a multifunctional bioactive glass. Numerous bioactive behaviors, including inhibiting bacterial and fungal adherence, antibacterial activity, neutralizing acids, preventing demineralization, and promoting remineralization, can be displayed by the discharged ions ( 6 ) . To the best of our knowledge, there is no study was carried out to compare between Beautifil Flow Plus X and ACTIVA so this study was conducted. Therefore, this study was conducted to evaluate the clinical performance of both composite restorations in class V cavities. The tested null hypothesis was that Beautifil Flow Plus X would show comparable clinical performance to ACTIVA bioactive in class V restorations over a period of 18-month. Materials and methods Study setting This study is 18 months follow-up evaluation of a prospective controlled randomized clinical parallel study design. The clinical performance of the two tested composite materials for the restoration of class V lesions in anterior teeth and premolars. The allocation ratio was 1:1. The study was carried out in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, after receiving approval of the Research Ethics Committee of Cairo University (CREC) (approval number 5-5-22). The researcher was in charge of all aspects of the study, including participant selection, explanation, and performance of procedures. The procedure and purpose of the study were described to the participants, and each one signed an informed consent. Trial design A total of 34 patients with class V cavities were enrolled randomly into two groups (n = 17 teeth for each group). Group 1: Beautifil Flow Plus X was used while in Group 2: ACTIVA Bioactive was used. USPH criteria was evaluated immediately after application and finishing (T0), after 6 months (T1), after 12 months (T2) and after 18 months (T3). Sample size calculation A power analysis was designed to have adequate power to apply statistical test (Statistical test used: Chi square test) of the research hypothesis to evaluate Giomer based restorative material compared to smart bioactive restorative material for class V restoration of carious teeth in terms of marginal discoloration after 18 months. According to the results of Nassar et al. ( 7 ) in which the probability of score A for marginal discoloration of smart bioactive material (comparator) was (0.867), probability of score C was (0.133) with effect size w = 0.734 (n = 15). The estimated probability of marginal discoloration for Giomer based restorative material (intervention) was (0.9) for score A, (0.1) for score C with effect size w = 0.8 (n = 13). By adopting an alpha (α) level of 0.05 (5%), power = 80%. The predicted sample size (n) was a total of (28). Sample size was increased by (20%) to account for anticipated missing data to be total of (34) cases i.e. (17) for each group. Samplesize calculation was performed using G*Power 3.1.9.2. Eligibility criteria The participants in this study were selected according to different exclusion and inclusion criteria revealed in table (1). Table (1): Patient and Teeth Inclusion and Exclusion criteria. Inclusion Criteria Exclusion Criteria • Patients ages 18 to 55 years. • Male or female. • Patients with good general health and recall availability. • Patients required class V restoration (premolar and anterior teeth) • Absence of any signs of irreversible pulpitis including spontaneous pain or pain on pressure. • Vital teeth with normal morphology. • Pregnant and lactating females. • Patients included in the evaluation of other restorative materials. • Patients with bruxism or parafunctional habits. • Teeth with non-carious lesios. • Non-vital or fractured teeth. • Teeth with advanced periodontal diseases. Randomization, allocation and blinding After applying the inclusion and exclusion criteria, the patients were randomly enrolled to two groups (Beautifil Flow Plus X or ACTIVA) based on randomized sequences created by the computer using Random Integer Generator ( www.randomization.com ). The allocation ratio was set to be equal, and the randomization was occurred at the tooth level rather than the patient level. During treatment, the type of material was concealed from the patient, and the patient had no idea which material would be used. The type of restoration was not mentioned in the patient’s file. Instead, it was replaced by a combination which is unfamiliar to the evaluators. Both the patients and the examiners were blinded to the material allocation. While the operator was not blinded because of the differences in packaging and manipulation of both tested materials. Restorative procedures Teeth that met the inclusion criteria were selected. Scaling and polishing was done one week before the study for all patients. Cavities were prepared using high-speed carbide round bur (MANI, INC, Japan) under water coolant. Finishing stone was used to round the internal line angles of the cavity. A 45 ̊ bevel 0.5 mm wide was prepared at the cavo-surface occlusal enamel margins in all cavities using tapered yellow finishing stone (Komet, USA). Spoon excavator (Dentsply maillefer size 51/52) was used to remove soft caries in case of deep cavities. The cavities are restored with the respective restorative materials (Fig. 1) ( 7 ) . Selective etching technique using phosphoric acid etching gel for 15 seconds was done, then air/water spray was used for 20 second followed by gentle drying to keep dentin wet. Single Bond TM Universal (Single Bond TM 3M Deutschland GmbH, Neuss, Germany) was applied to all the walls of the cavity using a disposable micro-brush with agitation for 20 seconds followed by 5 seconds of air dispersion, then light cure was used for 20 seconds (Fig. 2). For group 1: Beautifil Flow Plus X composite was placed according to manufacturer's instructions. Giomer material was applied to the cavity in an increments of 2 mm with polymerization od each increment for 10 seconds. The last increment is placed and carved to the required shape using an instrument for composite application (Fig. 3) ( 8 ) . For group 2: ACTIVA was manipulated following the manufacturer’s instructions. To prevent air bubbles, the dispenser tip was placed on the cavity floor keeping it submerged in the composite material. ACTIVA was applied in one bulk layer, gold plated composite applicator (Zeffiro, Lascod, Italy) was used to adapte the material in the cavity then it was light cured using light curing device (Woodpecker, China) for 20 seconds (Fig. 4) ( 9 ),( 10 ) . Fine yellow finishing stone (Komet, USA) was used with water cooling to contour and remove the excess of material followed by polishing using sof-lex discs (TOR VM Dental Manufacturing Company, Russia) ( 10 ) . All participants were instructed to follow oral hygiene measures (brush the teeth modified bass technique twice a day, floss once a day, consider a mouthwash) to avoid plaque and bacterial accumulation which might negatively affect the clinical performance of restoration. Table (2): Materials used in this study : Product Description Composition Manufacturer Lot Number Beautifil Flow Plus X Giomer bioactive material Bis-GMA, TEGDMA, Bis-MPEPP, S-PRG filler based on fluoro-boro-alumino-silicate glass, Polymerization initiator, Pigments and others ( 1 ) (Shofu Inc.,Kyoto, Japan) 102036 ACTIVA BioACTIVE Restorative Bioglass- reinforced resin modified glass ionomer Patented bioactive ionic resin. Patented rubberized resin. Bioactive ionic glass. Mix of methacrylates and diurethane with modified polyacrylic acid (44.6%); reactive glass filler (21.8wt.%); inorganic filler (56 wt. %). (2) Pulpdent Corporation, Watertown, MA, USA. 190513 3M ESPE Single Bond Universal Adhesive VMS Technology MDP Phosphate Monomer, Dimethacrylate resins, HEMA, Vitrebond Copolymer, Filler, Ethanol, Water, Initiators and Silane. ( 3 ) 3M ESPE, St. Paul, MN, USA 90809A Bis-GMA : Bis phenol glycidyl dimethacrylate, TEGDMA : Triethylene glycol dimethacrylate, Bis- MPEPP : Bisphenol A polyethoxy dimethacrylate or 2,2-bis(4-methacryloxy poly-ethoxyphenyl)propane, S-PRG : surface pre-reacted glass ionomer, UDMA : Urethanedimethacrylate, HEMA : 2-hydroxyethyl methacrylate, MDP : Methacryloyloxydecyl dihydrogen phosphate Table (3): Frequency (n), percentage (%) for all the USPHS criteria: Follow-up ACTIVA bioactive Beautifil flow plus X P value A B C A B C Marginal integrity Baseline 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 18 months 17(100%) 1(7.1%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) P value P = 1.0000(NS) P = 1.0000(NS) Postoperative hypersensitivity Baseline 17(100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17(100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17(100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 18 months 17(100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) P value P = 1.0000(NS) P = 1.0000(NS) Marginal discoloration Baseline 17(100%) 0 (0%) 0 (0%) 17(100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17(100%) 0 (0%) 0 (0%) 17(100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17(100%) 0 (0%) 0 (0%) 17(100%) 0 (0%) 0 (0%) 1.0000(NS) 18 months 17(100%) 0 (0%) 0 (0%) 17(100%) 0 (0%) 0 (0%) 1.0000(NS) P value P = 1.0000(NS) P = 1.0000(NS) Surface texture Baseline 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17 (100%) 0 (0%) 0 (0%) 13 (76.5%) 4 (23.5%) 0 (0%) 0.0359(NS) 18 months 13 (76.5%) 4 (23.5%) 0 (0%) 10 (58.8%) 4 (23.5%) 0 (0%) 0.2786(NS) P value P = 0.007(NS) P = 0.001(NS) Secondary caries Baseline 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000 (NS) 12 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000 (NS) 18 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000 (NS) P value 1.0000(NS) 1.0000(NS) Fracture & Retention Baseline 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 18 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) P value 1.0000(NS) 1.0000(NS) Anatomic form Baseline 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 6 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 12 months 17 (100%) 0 (0%) 0 (0%) 17 (100%) 0 (0%) 0 (0%) 1.0000(NS) 18 months 15 (88.2%) 2 (11.8%) 0 (0%) 14 (82.4%) 3 (17.6%) 0 (0%) 0.6333(NS) P value 0.112(NS) 0.029* *Statistically significant. NS: Non-significant Outcome assessment Restorations were evaluated during the three periods of follow-up (at baseline, after 6, 12, and 18 months). During this time, two examiners who were not involved in the restorative procedures were trained to assess the restorations using the modified United States Public Health Service (USPHS) criteria including: retention, marginal adaptation, marginal discoloration, postoperative sensitivity, secondary caries, anatomical form and surface texture. The restorations were scored as Alfa (A): The ideal clinical situation, Bravo (B):Clinically acceptable or Charlie (C): Clinically unacceptable. Evaluation was conducted with direct vison under a dental operating light, using mouth mirror, dental probe. Additionally, intraoral digital photos were taken for documentation.The agreement between examiners should not be less than 85% to be considered as significant. To facilitate the uniformity among examiners, when there was any uncertainty between the Alpha and Bravo scores rated by the two examiners, a third examiner was ready to decide the final score (7). Statistical analysis The data were analyzed using MedCalc software, version 22 for Windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data were presented as frequencies and percentages. Chi-Squared test was used for intergroup comparisons between the intervention group and the comparator group while Cochran’s Q test was used for intragroup comparison in each group followed by multiple comparisons. The clinical significance was assessed using relative risk. The Kaplan-meier and Log-rank tests were used to analyze the survival rate. The confidence limit was set at 95%, 80% power, with statistical significance level set at (P ≤ 0.05). All statistical tests conducted were two-tailed. Results The current study was carried out on (34) participants with cervical carious lesions, who were randomly assigned to either the intervention or the comparator groups (n = 17). After 18 months, all of the 34 patients completed the evaluation period with no dropout. The study followed CONSORT 2010 flow reporting guidelines (Fig. 6). Mean age of the patients in the present study was 30.1 ± 7.7 years; mean age in Active group was 30.8 ± 7.4 years, while the mean age in Beautifil group was 29.3 ± 8.2 years. There was no statistically significant difference in age between the two tested groups (P = 0.588). The teeth distribution analysis in the upper and lower arches revealed 20 maxillary anterior, 4 maxillary premolars, 4 mandibular anterior, and 6 mandibular premolars in the current study (P = 1.0000). Marginal integrity, Postoperative hypersensitivity, Marginal discoloration, Secondary caries, Fracture and Retention: There was no statistically significant difference in the intergroup comparisons between the two tested materials within different periods of evaluation. Intragroup comparison in ACTIVA bioactive and Beautifil flow plus X showed no statistically significant difference within different periods of evaluation (P = 1.0000). Surface texture: Intergroup comparisons showed no statistical significant difference between the two tested materials within different periods of evaluation; baseline and after 6 months (P > 0.05), while there was difference after 12 months (P = 0.0359). There was statistically significant difference in intragroup comparison in ACTIVA group within the periods of evaluation (P = 0.007). Intragroup comparison within Beautifil have shown statistically significant difference between different periods of evaluation (P = 0.001). There was 43% more risk of surface texture (score B) of ACTIVA when compared to Beautifil after 18 months. Anatomic form : Intergroup comparisons between the two tested materials showed no statistically significant difference between different periods of evaluation; baseline, after 6, 12 and 18 months (P > 0.05). Intragroup comparison in ACTIVA group showed no statistically significant difference within different periods of evaluation (P = 0.112). Intragroup comparison in Beautifil group showed statistically significant difference within different periods of evaluation (P = 0.029). (Table X and Figure X) There was 33% more risk of anatomic form (score B) of ACTIVA when compared to Beautifil after 18 months. Survival analysis: Overall survival of ACTIVA bioactive and Beautifil flow plus X for class V restorations was examined after 18 months. Four restorations were scored B in ACTIVA group, while 7 restorations scored B in Beautifil group after 18 months. Survival curves were obtained usin Kaplan-meier analysis while Logrank test were used for survival curves comparison (Fig. 7). the curve showed no statistically significant difference between the two tested materials (P = 0.1920). ACTIVA bioactive group has shown 76.5% alpha score, while Beautifil flow plus X group has shown 58.8% alpha score after 18 months with no difference between them (P = 0.2771), yet all restorations were considered successful. Discussion The main concern with cervical composite restorations is the microleakage, particularly at the cervical wall. This phenomenon is characterized by the infiltration of bacteria, fluids, molecules, or ions into the interface between cavity walls and restoration, leading to marginal discoloration, sensitivity and recurrent caries ( 11 ) . As that, the main cause for restoration replacement due to failure is recurrent caries ( 12 ) , remineralization was enhanced in recent bioactive restorative materials which can release and exchange different ions like, fluoride, calcium and phosphorous in oral environment. This property results in acid attack neutralization, caries inhibition and development of a protective layer on the surface of tooth ( 13 ) . ACTIVA is a bioactive restorative material that combine the bioactivity characteristic through responding to oral environment changes and chemical bond formation that decreases marginal leakage ( 14 ) . ACTIVA bioactive composed of bioactive ionic resin, rubberized resin and bioactive glass ionomer. It is superior to glass ionomer in fluoride release and like composite in resiliency, strength and esthetics. It also has no Bisphenol A, No Bis-GMA and no BPA in its contents ( 15 ) . Giomers are a novel type of hybrid material that consists of a stable glass-ionomer phase on a glass core formed by an acid-base reaction between fluoridated glass and polycarboxylic acid in the presence of water (S-PRG). This material has been demonstrated to have an anti-plaque action through reducing bacterial adherence on tooth surface. This property can treat hypersensitivity ( 16 ) . A surface pre-reacted glass ionomer (S-PRG) filler contains resinous materials which is able to release different ions in neutral and acidic environment, like aluminum, boron, fluoride, sodium, silicon, and strontium. The release of these ions can help in controlling caries progression ( 17 ) . The 10-meth-acryloyloxydecyl dihydrogen phosphate (10-MDP) monomer in single bond universal is a functional monomer that forms effective chemical interaction with residual hydroxyapatite that remained around the exposed collagen fibers in the hybrid layer. This intense chemical interaction provides a stable nanolayer that results in a stronger adhesive interface ( 11 ) . In this study, modified USPHS criteria were used due to its widespread and simple use in the evaluation of the important restorations criteria ( 18 ) . The restorations were evaluated in terms of marginal adaptation, marginal discoloration, postoperative hypersensitivity, secondary caries ,anatomic form and surface texture. The restorations were evaluated at baseline and at 6, 12, and 18-month intervals. This follow-up period can provide significant information about the clinical performance including success or failure, functional and biological ( 19 ) . Regarding the results of the present study, all restorations were examined without any dropout. Beautifil flow plus X has shown similar clinical performance to ACTIVA bioactive in restoring class V carious cavities after 18 months of clinical service. Age and gender have no significant impact on clinical performance of both materials. Therefore, the null hypothesis is accepted in our study. There was no significant difference in the clinical performance between the two tested materials over 18 months. Both tested materials showed accepted performance without any failure over the evaluation period of the study. Concerning the marginal adaptation of ACTIVA bioactive, all restorations were scored alpha over the evaluation period of this trial. These findings were in accordance with another study that found no statistically significant difference in marginal adaptation between ACTIVA bioactive composite and nanohybrid composite ( 20 ) . This can be explained by the dynamic ionic exchange between saliva and tooth structure, which improves tooth structure remineralization through continuous release and absorbance of fluoride, phosphate and calcium ions in response to the pH changes in oral cavity. This process fills the gaps that can enhance the marginal adaptation ( 21 ) . While the superior sealing ability of ACTIVA bioactive related to the ionization reaction that forms hydroxyapatite bond to the tooth structure (22) . Marginal leakage along the tooth restoration interface is believed to be the main cause of secondary caries ( 7 ) . The present findings revealed a positive link between secondary caries and marginal adaptation which was statistically significant in the two tested materials over the evaluation period of this study. There was no significant loss of marginal adaptation between the two evaluated restorative materials. Additionally, no secondary caries was found in both evaluated materials over eighteen months which was due to the usage of bioactive restorations that have an anticariogenic effect. ACTIVA did not show any marginal discoloration after 18 months, this was confirmed by another study reporting that the good bonding with tooth structure without microleakage was the cause of this finding ( 2 ) . Marginal discoloration is usually related to marginal integrity. The superior adaptation, accurate application and void free restoration of the two tested injectable materials (Beautifil flow plus x and ACTIVA bioactive) could explain this result. Also, the low modulus of elasticity of the injectable restorative materials which act as elastic buffer that can relieve stresses at the interface and resist the polymerization shrinkage of composite restoration ( 23 ) . For retention, both tested materials showed no statistically significant difference over the different periods of evaluation in both inter and intra group comparisons. Retention of restorations is related to bond strength ( 24 ) . The 100% retention rate of ACTIVA restoration recorded in our study over the period of evaluation was in agreement with a study done by Kaushik and Yadav who linked the results to the manufacturer`s recommendations for using bonding agent with ACTIVA restorations that enhanced the retention and bonding performance ( 2 ) . However, the present findings were not in accordance with those obtained by a study done by Bhadra. et al. that revealed (6.6%) loss of retention in ACTIVA bioactive group after one year. This confliction is attributed to the absence of adhesive bonding agent application in that study while it was applied in our study ( 20 ) . For Beautifil flow plus X composite, the results of this study are supported by another study done by Abdel-Karim. et al. and Ozer. et al. who stated that the low modulus of elasticity of Giomer-based injectable composite can relieve the stresses at the adhesive interfaces and improves the retention of restoration ( 23 ), ( 25 ) . The Postoperative sensitivity was deemed a subjective criteria as it depends on patient’s complaint. The two tested materials showed no statistically significant difference between different periods of evaluation in both inter and intra group comparisons. Because it depends on the patient's complaint, postoperative hypersensitivity was regarded as a subjective criterion. For Giomer-based injectable resin composite, the results of this study are in agreement with Abdel-Karim. et al. and Ozer. et al. who found that absence of postoperative hypersensitivity through the whole study could be due to the use of self-etch adhesive that can reduce the risk of postoperative sensitivity, as it only dissolves the smear layer and prime the dentin without removing of smear plugs as happened in the total-etch mode ( 23 ), ( 25 ) . For ACTIVA bioactive, this might be attributed to its composition which forms chemical bond with tooth structure, seals microleakage and improves marginal adaptation ( 7 ) . Regarding anatomical form, there was no significant difference between the groups at baseline, after 6, 12 and 18 months. These results are also in acceptance with another study which reported that the restorative composite material with small filler particle size which improves the restoration hardness, can maintain the anatomical form of the restoration ( 26 ) . While, intragroup comparison in Beautifil group have shown statistically significant difference between different periods of evaluation with 33% more risk of anatomic form loss. These current results could be supported by another study reporting that as S-PRG filler can release various types of ions that results in weight loss of the restoration. The weight loss of resin composite is directly related to solubility characteristics which has a bad impact on maintaining the anatomical form of the restoration ( 27 ) . Regarding surface texture, the two tested materials showed no significant difference between different periods of evaluation in intergroup comparisons. The microstructure and filler particle size could affect the surface roughness of different restorative materials ( 28 ) . The surface roughness increases with the increase in restorative material particle size ( 29 ) . The great improvement in the technology of the dental materials used in this study in addition to the same finishing and polishing protocol used for both groups explain the highly finished and polished surface. The low risk of surface texture of ACTIVA bioactive is due to the absence of Bis-GMA monomers that has a bad impact on surface texture through reducing the strength of restorative material ( 30 ) . While, there was significant difference between different periods of evaluation in intragroup comparison in Beautifil group with 43% more risk of surface texture. In accordance with another study done by Radwanski. et al. who stated that materials contained S-PRG fillers might cause microcrack formation and matrix-filler separation as a result of continuous releasing of ions that results in surface roughness ( 31 ) . These results were disagreed with those observed by Abdel-Karim. et al. and Ozer. et al. who reported that the presence of nano-sized filler particles of the giomer-based injectable composite could justify its high finished and polished surface ( 23 ), ( 25 ) . This confliction might be explained by the tendency of resin-based restorative materials with a high Bis-GMA content (Beautifil flow plus X contains 10–20% Bis-GMA) to absorb more water than other types of monomer containing composites. Furthermore, resin composite with larger filler particle sizes (Beautifil flow plus X filler size is 0.8 µm) possess more water sorption because of the larger surface area accessible for water absorption. This criterion increases composite solubility and has a bad impact on surface texture ( 27 ) . Concerning survival rate while comparing both materials, no statistically significant difference after 18 months follow up was found as illustrated by the survival curve as only four restorations scored B in ACTIVA bioactive composite group, and seven restorations scored B in Beautifil flow plus X group regarding surface texture. Accordingly, the results of the current study support the null hypothesis and confirm the comparable clinical performance of Beautifil flow plus X composite and ACTIVA bioactive in class V carious cavities over an 18-months follow up period. Despite the limitations of this clinical trial, such as its relatively small sample size, larger sample size might be valuable in identifying any difference between the two tested materials accurately. Moreover, the evaluation period of 18 months may not be fully accurate to evaluate the long-term survival of restorative material. As that, the modified USPHS criteria have some limitations such as it low sensitivity in complete capturing the clinical success of restorations, it is recommended to use the modified USPHS criteria in addition to FDI systems to guarantee the early detection of restoration deterioration ( 32 ) . Conclusions Under the limitations of this study, the following conclusions could be drawn: Both Beautifil flow plus X and ACTIVA bioactive have acceptable clinical performance after 18 months follow up period. Class V cavities could be restored either by Beautifil flow plus X or ACTIVA bioactive. Age, gender and teeth distribution have no effect on the results of clinical performance of restorative materials tested. Recommendations : Clinical trials with longer evaluation period are recommended to confirm the results of the present study. Clinical trials comparing the clinical performance of Giomer based injectable resin composite with other types of restorations in different clinical settings. To substantiate the current results, clinical assessment using revised FDI criteria for its higher sensitivity compared to Modified USPHS criteria and hosting of other factors are highly recommended in further clinical studies. A larger sample size is recommended as it could provide a solid foundation to validate the research findings. To minimize the variations between patients, split mouth study design is recommended. In vivo study using USPHS criteria in conjunction with SEM (Scanning Electron Microscope) replica images is recommended to support the current findings. Declarations Ethics approval and consent to participate Ethical approval was obtained by the Research Ethics Committee of Cairo University, Egypt (CREC) (approval number 5-6-22 with date of 28/6/2022). The study was carried out in accordance with the ethical guidelines outlined in the World Medical Association Declaration of Helsinki. As a result, all study participants provided informed consent to participate before starting the trial. Consent for publication Not applicable Competing interests The authors confirm that there are no potential conflicts of interest related to the research, authorship, or publication of this article. Funding No funding was received. Availability of data and materials The datasets utilized and/or analyzed in this study can be obtained from the corresponding author upon reasonable request. Authors’ contributions All authors (BR, HH, OH, and EA) were involved in the conception and design of the study. BR carried out the research, collected the data, and performed the analysis. BR, HH, OH, and EA collaborated in drafting the manuscript and made substantial revisions to it. Each author reviewed and approved the final version of the manuscript upon submission and agreed to take personal responsibility for the content of the work. Acknowledgment Not applicable References Elgezawi M, Haridy R, Abdalla MA, Heck K, Draenert M, Kaisarly D. Current strategies to control recurrent and residual caries with resin composite restorations: operator-and material-related factors. Journal of Clinical Medicine. 2022 Nov 7;11(21):6591. Kaushik M, Yadav M. Marginal microleakage properties of activa bioactive restorative and nanohybrid composite resin using two different adhesives in non carious cervical lesions-an in vitro study. Journal of the west african college of surgeons. 2017 Apr;7(2):1. Najma Hajira NS, Meena N. GIOMER-the intelligent particle (new generation glass ionomer cement). Int J Dent Oral Health. 2015;2(4):1-5. Matis BA, Cochran MA, Carlson TJ, Eckert GJ, Kulapongs KJ. Giomer composite and microfilled composite in clinical double blind study. InJournal of Dental Research 2002 Mar 1 (Vol. 81, pp. A80-A80). 1619 DUKE ST, ALEXANDRIA, VA 22314-3406 USA: INT AMER ASSOC DENTAL RESEARCHI ADR/AADR. Croll TP, Berg JH, Donly KJ. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent. 2015 Jan 1;36(1):60-5. Tonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue conditioner incorporating a nano-sized surface pre-reacted glass-ionomer (S-PRG) filler. Materials. 2021 Nov 4;14(21):6648. Nassar AA, El-Sayed HY, Etman WM, Genaid TM. Clinical evaluation of different bioactive dental restorative materials. Egyptian Dental Journal. 2020;4(4):1124-42. Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. Journal of Indian Society of Pedodontics and Preventive Dentistry. 2022 Jul 1;40(3):288-96. Essa M, Nassar A, Attia R. One-year comparative clinical evaluation of ACTIVA Bioactive restorative material with Nano hybrid composite resin in class V cavity preparation. Egyptian Dental Journal. 2022 Apr 1;68(2):1875-88. Yehia YH, Ibrahim AH, Abou-auf E, Elzogbhi AF. Clinical evaluation of bioactive restorative material versus resin modified glass ionomer in cervical restorations: a randomized controlled clinical trial. Open Access Macedonian Journal of Medical Sciences. 2022 Jan 5;10(D):33-40. Morsy KE, Abdalla AI, Shalaby ME. Clinical evaluation of three adhesive systems in class V carious lesions. Tanta Dental Journal. 2018 Jul 1;15(3):132-9. Elgezawi M, Haridy R, Abdalla MA, Heck K, Draenert M, Kaisarly D. Current strategies to control recurrent and residual caries with resin composite restorations: operator-and material-related factors. Journal of Clinical Medicine. 2022 Nov 7;11(21):6591. Garoushi S, Vallittu PK, Lassila L. Characterization of fluoride releasing restorative dental materials. Dental Materials Journal. 2018 Mar 26;37(2):293-300. Mosallam SM, Abdel-Gawad R, El-Shehaby F, Elchaghaby M. Evaluation of remineralization potential of activa bioactive restorative material versus resin modified glass ionomer in restoration of premolars: in vitro study. Acta Sci. Dent. Sci. 2021 Apr;5:2581-4893. Bishnoi N, de Ataide ID, Fernandes M, Lambor DR, Sandhu B. Evaluating the marginal seal of a bioactive restorative material activa bioactive and two bulk fill composites in class II restorations: an in vitro study. Int J Appl Dent Sci. 2020;6(3):98-102. Rusnac ME, Prodan D, Moldovan M, Cuc S, Filip M, Prejmerean C, Dudea D. Research on the Mechanical Properties, Fluoride and Monomer Release of a New Experimental Flowable Giomer in Comparison to Three Commercial Flowable Giomers. Applied Sciences. 2021 Sep 24;11(19):8921. Shimizu S, Kotake H, Takagaki T, Shinno K, Miyata S, Burrow MF, Hotta M, Nikaido T. Evaluation of bonding performance and multi-ion release of S-PRG fillercontaining self-adhesive resin composite. Dental Materials Journal. 2021 Sep 25;40(5):1257-63. Attia RM. TWO YEARS CLINICAL EVALUATION OF A BULK FILL COMPOSITE RESIN COMPARED WITH A NANOHYBRIDE INCREMENTAL FILL COMPOSITE RESIN IN CLASS ΙΙ CAVITIES. Egyptian Dental Journal. 2018 Apr 1;64(2-April (Fixed Prosthodontics, Dental Materials, Conservative Dentistry & Endodontics)):1547-59. El-Bialy MR, Shaalan OO, El-Zohairy AA, El-Zoghby AF. Clinical evaluation of glass ionomer with glass hybrid technology versus conventional high viscosity glass ionomer in class I cavities in patients with high caries risk: randomized controlled trial. Journal of International Oral Health. 2020 May 1;12(3):203-12. Bhadra D, Shah NC, Rao AS, Dedania MS, Bajpai N. A 1-year comparative evaluation of clinical performance of nanohybrid composite with Activa™ bioactive composite in Class II carious lesion: A randomized control study. Journal of Conservative Dentistry and Endodontics. 2019 Jan 1;22(1):92-6. Alrahlah A. Diametral tensile strength, flexural strength, and surface microhardness of bioactive bulk fill restorative. J contemp dent pract. 2018 Jan 1;19(1):13-9. Bishnoi N, de Ataide ID, Fernandes M, Lambor DR, Sandhu B. Evaluating the marginal seal of a bioactive restorative material activa bioactive and two bulk fill composites in class II restorations: an in vitro study. Int J Appl Dent Sci. 2020;6(3):98-102. Abdel-Karim UM, El-Eraky M, Etman WM. Three-year clinical evaluation of two nano-hybrid giomer restorative composites. Tanta Dental Journal. 2014 Dec 1;11(3):213-22. Vaid DS, Shah NC, Bilgi PS. One year comparative clinical evaluation of EQUIA with resin-modified glass ionomer and a nanohybrid composite in noncarious cervical lesions. Journal of Conservative Dentistry and Endodontics. 2015 Nov 1;18(6):449-52. Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five‐year clinical performance of two fluoride‐releasing giomer resin materials in occlusal restorations. Journal of Esthetic and Restorative Dentistry. 2022 Dec;34(8):1213-20. Garoushi S, Vallittu PK, Lassila L. Characterization of fluoride releasing restorative dental materials. Dental Materials Journal. 2018 Mar 26;37(2):293-300. Islam MS, Nassar M, Elsayed MA, Jameel DB, Ahmad TT, Rahman MM. In vitro optical and physical stability of resin composite materials with different filler characteristics. Polymers. 2023 Apr 29;15(9):2121. Jyothi KN, Annapurna S, Kumar AS, Venugopal P, Jayashankara CM. Clinical evaluation of giomer-and resin-modified glass ionomer cement in class V noncarious cervical lesions: An: in vivo: study. Journal of Conservative Dentistry. 2011 Oct 1;14(4):409-13. Kaptan A, Oznurhan F, Candan M. In vitro comparison of surface roughness, flexural, and microtensile strength of various glass-ionomer-based materials and a new alkasite restorative material. Polymers. 2023 Jan 27;15(3):650. Martínez-Sabio L, Peñate L, Arregui M, Veloso Duran A, Blanco JR, Guinot F. Comparison of shear bond strength and microleakage between activa™ bioactive restorative™ and bulk-fill composites—An in vitro study. Polymers. 2023 Jun 27;15(13):2840. Radwanski M, Zmyslowska-Polakowska E, Osica K, Krasowski M, Sauro S, Hardan L, Lukomska-Szymanska M. Mechanical properties of modern restorative “bioactive” dental materials-an in vitro study. Scientific Reports. 2025 Jan 28;15(1):3552. El-Gaaly AN, Hassan RR, Shaalan OO. Clinical evaluation of new bioactive restorative material versus resin modified glass ionomer in restoration of cervical carious lesions: Randomized clinical trial. Advanced Dental Journal. 2024 Apr 1;6(2):339-49. Additional Declarations No competing interests reported. Supplementary Files supplementaryfile.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6237005","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":440311305,"identity":"8893772d-9b9a-4d60-beda-ff6ea6bedc11","order_by":0,"name":"Basma Reda 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10:23:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6237005/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6237005/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":80584083,"identity":"929abb07-caac-4ae1-a7ce-643f5f0c6b76","added_by":"auto","created_at":"2025-04-15 00:16:41","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":71051,"visible":true,"origin":"","legend":"\u003cp\u003eTooth preparation. \u003cstrong\u003eA: \u003c/strong\u003eCavity preparation using carbide round bur\u003cstrong\u003e, B: \u003c/strong\u003eDeep caries removal using spoon excavator\u003cstrong\u003e, C: \u003c/strong\u003eBevel using yellow finishing stone\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/389f61af1d3113b613753626.jpg"},{"id":80584081,"identity":"f2e32cbf-0fd5-437e-bde2-6d2c6f06b3f2","added_by":"auto","created_at":"2025-04-15 00:16:41","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":41124,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eA: \u003c/strong\u003eSelective etching \u003cstrong\u003e, B: \u003c/strong\u003eSingle bond application\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/552eb33e297ced2cb3c2b58a.jpg"},{"id":80584082,"identity":"fc3a5955-0f82-4431-816a-07de309e1926","added_by":"auto","created_at":"2025-04-15 00:16:41","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":40679,"visible":true,"origin":"","legend":"\u003cp\u003eBeautifil flow x application\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/c7a7b89bb69e1443d29ca037.jpg"},{"id":80584646,"identity":"03af1165-afe6-467e-8cef-8aaa4c31b3f9","added_by":"auto","created_at":"2025-04-15 00:24:41","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":35812,"visible":true,"origin":"","legend":"\u003cp\u003eACTIVA bioactive application\u003c/p\u003e","description":"","filename":"4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/c2a19d7bbdf73f8d41f34482.jpg"},{"id":80584086,"identity":"4c730e70-711c-427f-b076-0a6271990fb5","added_by":"auto","created_at":"2025-04-15 00:16:42","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":42537,"visible":true,"origin":"","legend":"\u003cp\u003eFollow up after 18 month. \u003cstrong\u003eA\u003c/strong\u003e: Beautifil flow plus X,\u003cstrong\u003e B: \u003c/strong\u003eACTIVA bioactive.\u003c/p\u003e","description":"","filename":"5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/dea169aeb63ec14cb4602985.jpg"},{"id":80584087,"identity":"3d5d4aeb-77cf-4196-93ed-e9cb088dad6b","added_by":"auto","created_at":"2025-04-15 00:16:42","extension":"jpg","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":53301,"visible":true,"origin":"","legend":"\u003cp\u003eParticipants Flow Diagram\u003c/p\u003e","description":"","filename":"6.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/a01756c48168a421503e037b.jpg"},{"id":80584088,"identity":"57252201-67d9-4405-92c8-756817886848","added_by":"auto","created_at":"2025-04-15 00:16:42","extension":"jpg","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":25850,"visible":true,"origin":"","legend":"\u003cp\u003eSurvival analysis of Activa and Beautifil for cervical restorations after 18 months\u003c/p\u003e","description":"","filename":"7.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/59be134747144655b12c5a09.jpg"},{"id":86909138,"identity":"1de64602-9aa9-4881-9bcf-1fc19abf7fb5","added_by":"auto","created_at":"2025-07-17 04:46:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1399632,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/0595f366-59aa-43a6-b010-499a9d86d4f8.pdf"},{"id":80584105,"identity":"3deca3d7-e34a-4ffe-b57c-1d7740e5b23b","added_by":"auto","created_at":"2025-04-15 00:16:42","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":5393916,"visible":true,"origin":"","legend":"","description":"","filename":"supplementaryfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-6237005/v1/6381ec3aafae24c5581259c5.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities: An 18 month Randomized Clinical Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCaries was thought to be a progressive condition that needed to be completely removed in order to prepare a cavity. Since caries is now recognized as a disease that may be prevented and reversed, efforts have focused on reducing its occurrence and reversing early lesions through ion precipitation remineralization. Furthermore, selective caries removal approach was made feasible by the potential to remineralize dentin collagen that has been partially demineralized by caries. Nowadays, fully demineralized dentin matrix has been successfully remineralized using recent biomimetic remineralization techniques \u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThere are several materials available to restore class V cavities, including glass ionomer cement (GIC), resin modified GIC, and composite resin. Although composite resin is the most popular one because of its aesthetic strength, polymerization shrinkage which is the main drawback of composite that is the main cause of marginal gap and leakage.\u003c/p\u003e \u003cp\u003eThe term \"smart materials\" refers to the relatively new concept of bioactive restorative materials, which are stated to have more fluoride release than glass ionomers and react to PH changes in the oral cavity by absorbing calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure. These materials can be controlled by a variety of stimuli, including pH, moisture, temperature and stress, and they can return to their original state after removal of the stimulus. One such material is ACTIVA Bioactive restorative (Pulpdent, USA), which is made up of a patented bioactive shock-absorbing rubberized ionic-resin (Embrace resin) matrix with a small amount of water. It has no Bisphenol A, Bis-GMA or BPA monomer \u003csup\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAnother example of smart hybrid materials is Giomer which was introduced in 2000. It includes a stable glass\u0026ndash;ionomer phase on a glass core, which initiates an acid-base reaction between fluoride-containing glass and polycarboxylic acid in the presence of water, forming pre-reacted glass-ionomer (PRG) filler \u003csup\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThere are two types of Pre-Reacted Glass-ionomer (PRG) Filler. Full reaction type (FPRG) where the entire glass filler reacted with polycarboxylic acid and surface reaction type (SPRG) in which the surface of the glass filler reacted with poly acids \u003csup\u003e(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eS-PRGs are inorganic bioactive fillers with the added capability of ion release. Because S-PRG filler may release a variety of ions, including Al, B, F, Na, Si, and Sr, it is regarded as a multifunctional bioactive glass. Numerous bioactive behaviors, including inhibiting bacterial and fungal adherence, antibacterial activity, neutralizing acids, preventing demineralization, and promoting remineralization, can be displayed by the discharged ions\u003csup\u003e(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eTo the best of our knowledge, there is no study was carried out to compare between Beautifil Flow Plus X and ACTIVA so this study was conducted. Therefore, this study was conducted to evaluate the clinical performance of both composite restorations in class V cavities. The tested null hypothesis was that Beautifil Flow Plus X would show comparable clinical performance to ACTIVA bioactive in class V restorations over a period of 18-month.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting\u003c/h2\u003e \u003cp\u003eThis study is 18 months follow-up evaluation of a prospective controlled randomized clinical parallel study design. The clinical performance of the two tested composite materials for the restoration of class V lesions in anterior teeth and premolars. The allocation ratio was 1:1. The study was carried out in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, after receiving approval of the Research Ethics Committee of Cairo University (CREC) (approval number 5-5-22). The researcher was in charge of all aspects of the study, including participant selection, explanation, and performance of procedures. The procedure and purpose of the study were described to the participants, and each one signed an informed consent.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eTrial design\u003c/h3\u003e\n\u003cp\u003eA total of 34 patients with class V cavities were enrolled randomly into two groups (n\u0026thinsp;=\u0026thinsp;17 teeth for each group). Group 1: Beautifil Flow Plus X was used while in Group 2: ACTIVA Bioactive was used. USPH criteria was evaluated immediately after application and finishing (T0), after 6 months (T1), after 12 months (T2) and after 18 months (T3).\u003c/p\u003e\n\u003ch3\u003eSample size calculation\u003c/h3\u003e\n\u003cp\u003eA power analysis was designed to have adequate power to apply statistical test (Statistical test used: Chi square test) of the research hypothesis to evaluate Giomer based restorative material compared to smart bioactive restorative material for class V restoration of carious teeth in terms of marginal discoloration after 18 months. According to the results of \u003cb\u003eNassar et al.\u003c/b\u003e \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e in which the probability of score A for marginal discoloration of smart bioactive material (comparator) was (0.867), probability of score C was (0.133) with effect size w\u0026thinsp;=\u0026thinsp;0.734 (n\u0026thinsp;=\u0026thinsp;15). The estimated probability of marginal discoloration for Giomer based restorative material (intervention) was (0.9) for score A, (0.1) for score C with effect size w\u0026thinsp;=\u0026thinsp;0.8 (n\u0026thinsp;=\u0026thinsp;13). By adopting an alpha (α) level of 0.05 (5%), power\u0026thinsp;=\u0026thinsp;80%. The predicted sample size (n) was a total of (28). Sample size was increased by (20%) to account for anticipated missing data to be total of (34) cases i.e. (17) for each group. Samplesize calculation was performed using G*Power 3.1.9.2.\u003c/p\u003e\n\u003ch3\u003eEligibility criteria\u003c/h3\u003e\n\u003cp\u003eThe participants in this study were selected according to different exclusion and inclusion criteria revealed in table (1).\u003c/p\u003e \u003cp\u003e \u003cb\u003eTable\u0026nbsp;(1): Patient and Teeth Inclusion and Exclusion criteria.\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInclusion Criteria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExclusion Criteria\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Patients ages 18 to 55 years.\u003c/p\u003e \u003cp\u003e\u0026bull; Male or female.\u003c/p\u003e \u003cp\u003e\u0026bull; Patients with good general health and recall availability.\u003c/p\u003e \u003cp\u003e\u0026bull; Patients required class V restoration (premolar and anterior teeth)\u003c/p\u003e \u003cp\u003e\u0026bull; Absence of any signs of irreversible pulpitis including spontaneous pain or pain on pressure.\u003c/p\u003e \u003cp\u003e\u0026bull; Vital teeth with normal morphology.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Pregnant and lactating females.\u003c/p\u003e \u003cp\u003e\u0026bull; Patients included in the evaluation of other restorative materials.\u003c/p\u003e \u003cp\u003e\u0026bull; Patients with bruxism or parafunctional habits.\u003c/p\u003e \u003cp\u003e\u0026bull; Teeth with non-carious lesios.\u003c/p\u003e \u003cp\u003e\u0026bull; Non-vital or fractured teeth.\u003c/p\u003e \u003cp\u003e\u0026bull; Teeth with advanced periodontal diseases.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eRandomization, allocation and blinding\u003c/h3\u003e\n\u003cp\u003eAfter applying the inclusion and exclusion criteria, the patients were randomly enrolled to two groups (Beautifil Flow Plus X or ACTIVA) based on randomized sequences created by the computer using Random Integer Generator (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.randomization.com\u003c/span\u003e\u003cspan address=\"http://www.randomization.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). The allocation ratio was set to be equal, and the randomization was occurred at the tooth level rather than the patient level. During treatment, the type of material was concealed from the patient, and the patient had no idea which material would be used. The type of restoration was not mentioned in the patient\u0026rsquo;s file. Instead, it was replaced by a combination which is unfamiliar to the evaluators. Both the patients and the examiners were blinded to the material allocation. While the operator was not blinded because of the differences in packaging and manipulation of both tested materials.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eRestorative procedures\u003c/h2\u003e \u003cp\u003eTeeth that met the inclusion criteria were selected. Scaling and polishing was done one week before the study for all patients. Cavities were prepared using high-speed carbide round bur (MANI, INC, Japan) under water coolant. Finishing stone was used to round the internal line angles of the cavity. A 45 ̊ bevel 0.5 mm wide was prepared at the cavo-surface occlusal enamel margins in all cavities using tapered yellow finishing stone (Komet, USA). Spoon excavator (Dentsply maillefer size 51/52) was used to remove soft caries in case of deep cavities. The cavities are restored with the respective restorative materials (Fig.\u0026nbsp;1) \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSelective etching technique using phosphoric acid etching gel for 15 seconds was done, then air/water spray was used for 20 second followed by gentle drying to keep dentin wet. Single Bond TM Universal (Single Bond TM 3M Deutschland GmbH, Neuss, Germany) was applied to all the walls of the cavity using a disposable micro-brush with agitation for 20 seconds followed by 5 seconds of air dispersion, then light cure was used for 20 seconds (Fig.\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eFor group 1: Beautifil Flow Plus X composite was placed according to manufacturer's instructions. Giomer material was applied to the cavity in an increments of 2 mm with polymerization od each increment for 10 seconds. The last increment is placed and carved to the required shape using an instrument for composite application (Fig.\u0026nbsp;3) \u003csup\u003e(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor group 2: ACTIVA was manipulated following the manufacturer\u0026rsquo;s instructions. To prevent air bubbles, the dispenser tip was placed on the cavity floor keeping it submerged in the composite material. ACTIVA was applied in one bulk layer, gold plated composite applicator (Zeffiro, Lascod, Italy) was used to adapte the material in the cavity then it was light cured using light curing device (Woodpecker, China) for 20 seconds (Fig.\u0026nbsp;4) \u003csup\u003e(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e),(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFine yellow finishing stone (Komet, USA) was used with water cooling to contour and remove the excess of material followed by polishing using sof-lex discs (TOR VM Dental Manufacturing Company, Russia) \u003csup\u003e(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e All participants were instructed to follow oral hygiene measures (brush the teeth modified bass technique twice a day, floss once a day, consider a mouthwash) to avoid plaque and bacterial accumulation which might negatively affect the clinical performance of restoration.\u003c/p\u003e \u003cp\u003e \u003cb\u003eTable\u0026nbsp;(2): Materials used in this study\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Tabb\" border=\"1\"\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProduct\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDescription\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eComposition\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eManufacturer\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eLot Number\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBeautifil Flow Plus X\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGiomer bioactive material\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBis-GMA, TEGDMA, Bis-MPEPP, S-PRG filler based on fluoro-boro-alumino-silicate glass, Polymerization initiator, Pigments and others \u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(Shofu Inc.,Kyoto, Japan)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e102036\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eACTIVA BioACTIVE\u003c/p\u003e \u003cp\u003eRestorative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBioglass- reinforced resin modified glass ionomer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePatented bioactive ionic resin. Patented rubberized resin. Bioactive ionic glass. Mix of methacrylates and diurethane with modified polyacrylic acid (44.6%); reactive glass filler (21.8wt.%); inorganic filler (56 wt. %).\u003csup\u003e(2)\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePulpdent Corporation, Watertown, MA, USA.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e190513\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3M ESPE Single Bond Universal Adhesive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVMS Technology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMDP Phosphate Monomer, Dimethacrylate resins, HEMA, Vitrebond Copolymer, Filler, Ethanol, Water, Initiators\u003c/p\u003e \u003cp\u003eand Silane. \u003csup\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3M ESPE, St. Paul, MN, USA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e90809A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003cb\u003eBis-GMA\u003c/b\u003e: Bis phenol glycidyl dimethacrylate, \u003cb\u003eTEGDMA\u003c/b\u003e: Triethylene glycol dimethacrylate, Bis-\u003cb\u003eMPEPP\u003c/b\u003e: Bisphenol A polyethoxy dimethacrylate or 2,2-bis(4-methacryloxy poly-ethoxyphenyl)propane, \u003cb\u003eS-PRG\u003c/b\u003e: surface pre-reacted glass ionomer, \u003cb\u003eUDMA\u003c/b\u003e: Urethanedimethacrylate, \u003cb\u003eHEMA\u003c/b\u003e: 2-hydroxyethyl methacrylate, \u003cb\u003eMDP\u003c/b\u003e: Methacryloyloxydecyl dihydrogen phosphate\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\u003cp\u003e\u003cstrong\u003eTable (3): Frequency (n), percentage (%) for all the USPHS criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"595\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 199px;\"\u003e\n \u003cp\u003eACTIVA bioactive\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eBeautifil flow plus X\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003eA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003eA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003eB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMarginal integrity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1(7.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 199px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePostoperative hypersensitivity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 67px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 67px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 67px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 67px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 199px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 102px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMarginal discoloration\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17(100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 199px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eP = 1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSurface texture\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e13 (76.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e4 (23.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e0.0359(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e13 (76.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e4 (23.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e10 (58.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 74px;\"\u003e\n \u003cp\u003e4 (23.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e0.2786(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 48px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 199px;\"\u003e\n \u003cp\u003eP = 0.007(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eP = 0.001(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary caries\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000\u003c/p\u003e\n \u003cp\u003e(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000\u003c/p\u003e\n \u003cp\u003e(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000\u003c/p\u003e\n \u003cp\u003e(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 190px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFracture \u0026amp; Retention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 190px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnatomic form\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1.0000(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003e18 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e15 (88.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e2 (11.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 58px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\" \" valign=\"top\" style=\"width: 64px;\"\u003e\n \u003cp\u003e14 (82.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 68px;\"\u003e\n \u003cp\u003e3 (17.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 59px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e0.6333(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003e0.112(NS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 190px;\"\u003e\n \u003cp\u003e0.029*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*Statistically significant. NS: Non-significant\u003c/p\u003e\n\u003ch3\u003eOutcome assessment\u003c/h3\u003e\n\u003cp\u003eRestorations were evaluated during the three periods of follow-up (at baseline, after 6, 12, and 18 months). During this time, two examiners who were not involved in the restorative procedures were trained to assess the restorations using the modified United States Public Health Service (USPHS) criteria including: retention, marginal adaptation, marginal discoloration, postoperative sensitivity, secondary caries, anatomical form and surface texture. The restorations were scored as Alfa (A): The ideal clinical situation, Bravo (B):Clinically acceptable or Charlie (C): Clinically unacceptable. Evaluation was conducted with direct vison under a dental operating light, using mouth mirror, dental probe. Additionally, intraoral digital photos were taken for documentation.The agreement between examiners should not be less than 85% to be considered as significant. To facilitate the uniformity among examiners, when there was any uncertainty between the Alpha and Bravo scores rated by the two examiners, a third examiner was ready to decide the final score (7).\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe data were analyzed using MedCalc software, version 22 for Windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data were presented as frequencies and percentages. Chi-Squared test was used for intergroup comparisons between the intervention group and the comparator group while Cochran\u0026rsquo;s Q test was used for intragroup comparison in each group followed by multiple comparisons. The clinical significance was assessed using relative risk. The Kaplan-meier and Log-rank tests were used to analyze the survival rate. The confidence limit was set at 95%, 80% power, with statistical significance level set at (P\u0026thinsp;\u0026le;\u0026thinsp;0.05). All statistical tests conducted were two-tailed.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe current study was carried out on (34) participants with cervical carious lesions, who were randomly assigned to either the intervention or the comparator groups (n\u0026thinsp;=\u0026thinsp;17). After 18 months, all of the 34 patients completed the evaluation period with no dropout. The study followed CONSORT 2010 flow reporting guidelines (Fig.\u0026nbsp;6). Mean age of the patients in the present study was 30.1\u0026thinsp;\u0026plusmn;\u0026thinsp;7.7 years; mean age in Active group was 30.8\u0026thinsp;\u0026plusmn;\u0026thinsp;7.4 years, while the mean age in Beautifil group was 29.3\u0026thinsp;\u0026plusmn;\u0026thinsp;8.2 years. There was no statistically significant difference in age between the two tested groups (P\u0026thinsp;=\u0026thinsp;0.588). The teeth distribution analysis in the upper and lower arches revealed 20 maxillary anterior, 4 maxillary premolars, 4 mandibular anterior, and 6 mandibular premolars in the current study (P\u0026thinsp;=\u0026thinsp;1.0000).\u003c/p\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eMarginal integrity, Postoperative hypersensitivity, Marginal discoloration, Secondary caries, Fracture and Retention:\u003c/h2\u003e \u003cp\u003eThere was no statistically significant difference in the intergroup comparisons between the two tested materials within different periods of evaluation. Intragroup comparison in ACTIVA bioactive and Beautifil flow plus X showed no statistically significant difference within different periods of evaluation (P\u0026thinsp;=\u0026thinsp;1.0000).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSurface texture:\u003c/h2\u003e \u003cp\u003eIntergroup comparisons showed no statistical significant difference between the two tested materials within different periods of evaluation; baseline and after 6 months (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05), while there was difference after 12 months (P\u0026thinsp;=\u0026thinsp;0.0359). There was statistically significant difference in intragroup comparison in ACTIVA group within the periods of evaluation (P\u0026thinsp;=\u0026thinsp;0.007). Intragroup comparison within Beautifil have shown statistically significant difference between different periods of evaluation (P\u0026thinsp;=\u0026thinsp;0.001). There was 43% more risk of surface texture (score B) of ACTIVA when compared to Beautifil after 18 months.\u003c/p\u003e \u003cp\u003e \u003cb\u003eAnatomic form\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e Intergroup comparisons between the two tested materials showed no statistically significant difference between different periods of evaluation; baseline, after 6, 12 and 18 months (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Intragroup comparison in ACTIVA group showed no statistically significant difference within different periods of evaluation (P\u0026thinsp;=\u0026thinsp;0.112). Intragroup comparison in Beautifil group showed statistically significant difference within different periods of evaluation (P\u0026thinsp;=\u0026thinsp;0.029). (Table X and Figure X) There was 33% more risk of anatomic form (score B) of ACTIVA when compared to Beautifil after 18 months.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSurvival analysis:\u003c/h2\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eOverall survival of ACTIVA bioactive and Beautifil flow plus X for class V restorations was examined after 18 months. Four restorations were scored B in ACTIVA group, while 7 restorations scored B in Beautifil group after 18 months. Survival curves were obtained usin Kaplan-meier analysis while Logrank test were used for survival curves comparison (Fig.\u0026nbsp;7). the curve showed no statistically significant difference between the two tested materials (P\u0026thinsp;=\u0026thinsp;0.1920). ACTIVA bioactive group has shown 76.5% alpha score, while Beautifil flow plus X group has shown 58.8% alpha score after 18 months with no difference between them (P\u0026thinsp;=\u0026thinsp;0.2771), yet all restorations were considered successful.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe main concern with cervical composite restorations is the microleakage, particularly at the cervical wall. This phenomenon is characterized by the infiltration of bacteria, fluids, molecules, or ions into the interface between cavity walls and restoration, leading to marginal discoloration, sensitivity and recurrent caries \u003csup\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAs that, the main cause for restoration replacement due to failure is recurrent caries \u003csup\u003e(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/sup\u003e, remineralization was enhanced in recent bioactive restorative materials which can release and exchange different ions like, fluoride, calcium and phosphorous in oral environment. This property results in acid attack neutralization, caries inhibition and development of a protective layer on the surface of tooth \u003csup\u003e(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eACTIVA is a bioactive restorative material that combine the bioactivity characteristic through responding to oral environment changes and chemical bond formation that decreases marginal leakage \u003csup\u003e(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/sup\u003e. ACTIVA bioactive composed of bioactive ionic resin, rubberized resin and bioactive glass ionomer. It is superior to glass ionomer in fluoride release and like composite in resiliency, strength and esthetics. It also has no Bisphenol A, No Bis-GMA and no BPA in its contents \u003csup\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eGiomers are a novel type of hybrid material that consists of a stable glass-ionomer phase on a glass core formed by an acid-base reaction between fluoridated glass and polycarboxylic acid in the presence of water (S-PRG). This material has been demonstrated to have an anti-plaque action through reducing bacterial adherence on tooth surface. This property can treat hypersensitivity \u003csup\u003e(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eA surface pre-reacted glass ionomer (S-PRG) filler contains resinous materials which is able to release different ions in neutral and acidic environment, like aluminum, boron, fluoride, sodium, silicon, and strontium. The release of these ions can help in controlling caries progression \u003csup\u003e(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe 10-meth-acryloyloxydecyl dihydrogen phosphate (10-MDP) monomer in single bond universal is a functional monomer that forms effective chemical interaction with residual hydroxyapatite that remained around the exposed collagen fibers in the hybrid layer. This intense chemical interaction provides a stable nanolayer that results in a stronger adhesive interface \u003csup\u003e(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn this study, modified USPHS criteria were used due to its widespread and simple use in the evaluation of the important restorations criteria \u003csup\u003e(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/sup\u003e. The restorations were evaluated in terms of marginal adaptation, marginal discoloration, postoperative hypersensitivity, secondary caries ,anatomic form and surface texture.\u003c/p\u003e \u003cp\u003eThe restorations were evaluated at baseline and at 6, 12, and 18-month intervals. This follow-up period can provide significant information about the clinical performance including success or failure, functional and biological \u003csup\u003e(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eRegarding the results of the present study, all restorations were examined without any dropout. Beautifil flow plus X has shown similar clinical performance to ACTIVA bioactive in restoring class V carious cavities after 18 months of clinical service. Age and gender have no significant impact on clinical performance of both materials.\u003c/p\u003e \u003cp\u003eTherefore, the null hypothesis is accepted in our study. There was no significant difference in the clinical performance between the two tested materials over 18 months. Both tested materials showed accepted performance without any failure over the evaluation period of the study.\u003c/p\u003e \u003cp\u003eConcerning the marginal adaptation of ACTIVA bioactive, all restorations were scored alpha over the evaluation period of this trial. These findings were in accordance with another study that found no statistically significant difference in marginal adaptation between ACTIVA bioactive composite and nanohybrid composite \u003csup\u003e(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/sup\u003e. This can be explained by the dynamic ionic exchange between saliva and tooth structure, which improves tooth structure remineralization through continuous release and absorbance of fluoride, phosphate and calcium ions in response to the pH changes in oral cavity. This process fills the gaps that can enhance the marginal adaptation \u003csup\u003e(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhile the superior sealing ability of ACTIVA bioactive related to the ionization reaction that forms hydroxyapatite bond to the tooth structure \u003csup\u003e(22)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eMarginal leakage along the tooth restoration interface is believed to be the main cause of secondary caries \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e. The present findings revealed a positive link between secondary caries and marginal adaptation which was statistically significant in the two tested materials over the evaluation period of this study. There was no significant loss of marginal adaptation between the two evaluated restorative materials. Additionally, no secondary caries was found in both evaluated materials over eighteen months which was due to the usage of bioactive restorations that have an anticariogenic effect.\u003c/p\u003e \u003cp\u003eACTIVA did not show any marginal discoloration after 18 months, this was confirmed by another study reporting that the good bonding with tooth structure without microleakage was the cause of this finding \u003csup\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eMarginal discoloration is usually related to marginal integrity. The superior adaptation, accurate application and void free restoration of the two tested injectable materials (Beautifil flow plus x and ACTIVA bioactive) could explain this result. Also, the low modulus of elasticity of the injectable restorative materials which act as elastic buffer that can relieve stresses at the interface and resist the polymerization shrinkage of composite restoration \u003csup\u003e(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor retention, both tested materials showed no statistically significant difference over the different periods of evaluation in both inter and intra group comparisons. Retention of restorations is related to bond strength \u003csup\u003e(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe 100% retention rate of ACTIVA restoration recorded in our study over the period of evaluation was in agreement with a study done by Kaushik and Yadav who linked the results to the manufacturer`s recommendations for using bonding agent with ACTIVA restorations that enhanced the retention and bonding performance \u003csup\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eHowever, the present findings were not in accordance with those obtained by a study done by Bhadra. et al. that revealed (6.6%) loss of retention in ACTIVA bioactive group after one year. This confliction is attributed to the absence of adhesive bonding agent application in that study while it was applied in our study \u003csup\u003e(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor Beautifil flow plus X composite, the results of this study are supported by another study done by Abdel-Karim. et al. and Ozer. et al. who stated that the low modulus of elasticity of Giomer-based injectable composite can relieve the stresses at the adhesive interfaces and improves the retention of restoration \u003csup\u003e(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe Postoperative sensitivity was deemed a subjective criteria as it depends on patient\u0026rsquo;s complaint. The two tested materials showed no statistically significant difference between different periods of evaluation in both inter and intra group comparisons.\u003c/p\u003e \u003cp\u003eBecause it depends on the patient's complaint, postoperative hypersensitivity was regarded as a subjective criterion.\u003c/p\u003e \u003cp\u003eFor Giomer-based injectable resin composite, the results of this study are in agreement with Abdel-Karim. et al. and Ozer. et al. who found that absence of postoperative hypersensitivity through the whole study could be due to the use of self-etch adhesive that can reduce the risk of postoperative sensitivity, as it only dissolves the smear layer and prime the dentin without removing of smear plugs as happened in the total-etch mode \u003csup\u003e(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor ACTIVA bioactive, this might be attributed to its composition which forms chemical bond with tooth structure, seals microleakage and improves marginal adaptation \u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eRegarding anatomical form, there was no significant difference between the groups at baseline, after 6, 12 and 18 months. These results are also in acceptance with another study which reported that the restorative composite material with small filler particle size which improves the restoration hardness, can maintain the anatomical form of the restoration \u003csup\u003e(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhile, intragroup comparison in Beautifil group have shown statistically significant difference between different periods of evaluation with 33% more risk of anatomic form loss. These current results could be supported by another study reporting that as S-PRG filler can release various types of ions that results in weight loss of the restoration. The weight loss of resin composite is directly related to solubility characteristics which has a bad impact on maintaining the anatomical form of the restoration \u003csup\u003e(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eRegarding surface texture, the two tested materials showed no significant difference between different periods of evaluation in intergroup comparisons. The microstructure and filler particle size could affect the surface roughness of different restorative materials \u003csup\u003e(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)\u003c/sup\u003e. The surface roughness increases with the increase in restorative material particle size \u003csup\u003e(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/sup\u003e. The great improvement in the technology of the dental materials used in this study in addition to the same finishing and polishing protocol used for both groups explain the highly finished and polished surface.\u003c/p\u003e \u003cp\u003eThe low risk of surface texture of ACTIVA bioactive is due to the absence of Bis-GMA monomers that has a bad impact on surface texture through reducing the strength of restorative material \u003csup\u003e(\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhile, there was significant difference between different periods of evaluation in intragroup comparison in Beautifil group with 43% more risk of surface texture. In accordance with another study done by Radwanski. et al. who stated that materials contained S-PRG fillers might cause microcrack formation and matrix-filler separation as a result of continuous releasing of ions that results in surface roughness \u003csup\u003e(\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThese results were disagreed with those observed by Abdel-Karim. et al. and Ozer. et al. who reported that the presence of nano-sized filler particles of the giomer-based injectable composite could justify its high finished and polished surface \u003csup\u003e(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThis confliction might be explained by the tendency of resin-based restorative materials with a high Bis-GMA content (Beautifil flow plus X contains 10\u0026ndash;20% Bis-GMA) to absorb more water than other types of monomer containing composites. Furthermore, resin composite with larger filler particle sizes (Beautifil flow plus X filler size is 0.8 \u0026micro;m) possess more water sorption because of the larger surface area accessible for water absorption. This criterion increases composite solubility and has a bad impact on surface texture \u003csup\u003e(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eConcerning survival rate while comparing both materials, no statistically significant difference after 18 months follow up was found as illustrated by the survival curve as only four restorations scored B in ACTIVA bioactive composite group, and seven restorations scored B in Beautifil flow plus X group regarding surface texture. Accordingly, the results of the current study support the null hypothesis and confirm the comparable clinical performance of Beautifil flow plus X composite and ACTIVA bioactive in class V carious cavities over an 18-months follow up period.\u003c/p\u003e \u003cp\u003eDespite the limitations of this clinical trial, such as its relatively small sample size, larger sample size might be valuable in identifying any difference between the two tested materials accurately. Moreover, the evaluation period of 18 months may not be fully accurate to evaluate the long-term survival of restorative material. As that, the modified USPHS criteria have some limitations such as it low sensitivity in complete capturing the clinical success of restorations, it is recommended to use the modified USPHS criteria in addition to FDI systems to guarantee the early detection of restoration deterioration \u003csup\u003e(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eUnder the limitations of this study, the following conclusions could be drawn:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eBoth Beautifil flow plus X and ACTIVA bioactive have acceptable clinical performance after 18 months follow up period.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eClass V cavities could be restored either by Beautifil flow plus X or ACTIVA bioactive.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAge, gender and teeth distribution have no effect on the results of clinical performance of restorative materials tested.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eRecommendations\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eClinical trials with longer evaluation period are recommended to confirm the results of the present study.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eClinical trials comparing the clinical performance of Giomer based injectable resin composite with other types of restorations in different clinical settings.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo substantiate the current results, clinical assessment using revised FDI criteria for its higher sensitivity compared to Modified USPHS criteria and hosting of other factors are highly recommended in further clinical studies.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eA larger sample size is recommended as it could provide a solid foundation to validate the research findings.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo minimize the variations between patients, split mouth study design is recommended.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eIn vivo study using USPHS criteria in conjunction with SEM (Scanning Electron Microscope) replica images is recommended to support the current findings.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;and consent to participate\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was obtained by the Research Ethics Committee of Cairo University, Egypt (CREC)\u0026nbsp;(approval number 5-6-22 with date of 28/6/2022).\u0026nbsp;The study\u0026nbsp;was carried out in accordance with\u0026nbsp;the ethical guidelines outlined in the World Medical Association Declaration of Helsinki. As a result, all study participants provided informed consent to participate\u0026nbsp;before starting\u0026nbsp;the\u0026nbsp;trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors confirm that there are no potential conflicts of interest related to the research, authorship, or publication of this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets utilized and/or analyzed in this study can be obtained from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors (BR, HH, OH, and EA) were involved in the conception and design of the study. BR carried out the research, collected the data, and performed the analysis. BR, HH, OH, and EA collaborated in drafting the manuscript and made substantial revisions to it. Each author reviewed and approved the final version of the manuscript upon submission and agreed to take personal responsibility for the content of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eElgezawi M, Haridy R, Abdalla MA, Heck K, Draenert M, Kaisarly D. Current strategies to control recurrent and residual caries with resin composite restorations: operator-and material-related factors. Journal of Clinical Medicine. 2022 Nov 7;11(21):6591.\u003c/li\u003e\n\u003cli\u003eKaushik M, Yadav M. Marginal microleakage properties of activa bioactive restorative and nanohybrid composite resin using two different adhesives in non carious cervical lesions-an in vitro study. Journal of the west african college of surgeons. 2017 Apr;7(2):1.\u003c/li\u003e\n\u003cli\u003eNajma Hajira NS, Meena N. GIOMER-the intelligent particle (new generation glass ionomer cement). Int J Dent Oral Health. 2015;2(4):1-5.\u003c/li\u003e\n\u003cli\u003eMatis BA, Cochran MA, Carlson TJ, Eckert GJ, Kulapongs KJ. Giomer composite and microfilled composite in clinical double blind study. InJournal of Dental Research 2002 Mar 1 (Vol. 81, pp. A80-A80). 1619 DUKE ST, ALEXANDRIA, VA 22314-3406 USA: INT AMER ASSOC DENTAL RESEARCHI ADR/AADR.\u003c/li\u003e\n\u003cli\u003eCroll TP, Berg JH, Donly KJ. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent. 2015 Jan 1;36(1):60-5.\u003c/li\u003e\n\u003cli\u003eTonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue conditioner incorporating a nano-sized surface pre-reacted glass-ionomer (S-PRG) filler. Materials. 2021 Nov 4;14(21):6648.\u003c/li\u003e\n\u003cli\u003eNassar AA, El-Sayed HY, Etman WM, Genaid TM. Clinical evaluation of different bioactive dental restorative materials. Egyptian Dental Journal. 2020;4(4):1124-42.\u003c/li\u003e\n\u003cli\u003eDeepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. Journal of Indian Society of Pedodontics and Preventive Dentistry. 2022 Jul 1;40(3):288-96.\u003c/li\u003e\n\u003cli\u003eEssa M, Nassar A, Attia R. One-year comparative clinical evaluation of ACTIVA Bioactive restorative material with Nano hybrid composite resin in class V cavity preparation. Egyptian Dental Journal. 2022 Apr 1;68(2):1875-88.\u003c/li\u003e\n\u003cli\u003eYehia YH, Ibrahim AH, Abou-auf E, Elzogbhi AF. Clinical evaluation of bioactive restorative material versus resin modified glass ionomer in cervical restorations: a randomized controlled clinical trial. Open Access Macedonian Journal of Medical Sciences. 2022 Jan 5;10(D):33-40.\u003c/li\u003e\n\u003cli\u003eMorsy KE, Abdalla AI, Shalaby ME. Clinical evaluation of three adhesive systems in class V carious lesions. Tanta Dental Journal. 2018 Jul 1;15(3):132-9.\u003c/li\u003e\n\u003cli\u003eElgezawi M, Haridy R, Abdalla MA, Heck K, Draenert M, Kaisarly D. Current strategies to control recurrent and residual caries with resin composite restorations: operator-and material-related factors. Journal of Clinical Medicine. 2022 Nov 7;11(21):6591.\u003c/li\u003e\n\u003cli\u003eGaroushi S, Vallittu PK, Lassila L. Characterization of fluoride releasing restorative dental materials. Dental Materials Journal. 2018 Mar 26;37(2):293-300.\u003c/li\u003e\n\u003cli\u003eMosallam SM, Abdel-Gawad R, El-Shehaby F, Elchaghaby M. Evaluation of remineralization potential of activa bioactive restorative material versus resin modified glass ionomer in restoration of premolars: in vitro study. Acta Sci. Dent. Sci. 2021 Apr;5:2581-4893.\u003c/li\u003e\n\u003cli\u003eBishnoi N, de Ataide ID, Fernandes M, Lambor DR, Sandhu B. Evaluating the marginal seal of a bioactive restorative material activa bioactive and two bulk fill composites in class II restorations: an in vitro study. Int J Appl Dent Sci. 2020;6(3):98-102.\u003c/li\u003e\n\u003cli\u003eRusnac ME, Prodan D, Moldovan M, Cuc S, Filip M, Prejmerean C, Dudea D. Research on the Mechanical Properties, Fluoride and Monomer Release of a New Experimental Flowable Giomer in Comparison to Three Commercial Flowable Giomers. Applied Sciences. 2021 Sep 24;11(19):8921.\u003c/li\u003e\n\u003cli\u003eShimizu S, Kotake H, Takagaki T, Shinno K, Miyata S, Burrow MF, Hotta M, Nikaido T. Evaluation of bonding performance and multi-ion release of S-PRG fillercontaining self-adhesive resin composite. Dental Materials Journal. 2021 Sep 25;40(5):1257-63.\u003c/li\u003e\n\u003cli\u003eAttia RM. TWO YEARS CLINICAL EVALUATION OF A BULK FILL COMPOSITE RESIN COMPARED WITH A NANOHYBRIDE INCREMENTAL FILL COMPOSITE RESIN IN CLASS \u0026Iota;\u0026Iota; CAVITIES. Egyptian Dental Journal. 2018 Apr 1;64(2-April (Fixed Prosthodontics, Dental Materials, Conservative Dentistry \u0026amp; Endodontics)):1547-59.\u003c/li\u003e\n\u003cli\u003eEl-Bialy MR, Shaalan OO, El-Zohairy AA, El-Zoghby AF. Clinical evaluation of glass ionomer with glass hybrid technology versus conventional high viscosity glass ionomer in class I cavities in patients with high caries risk: randomized controlled trial. Journal of International Oral Health. 2020 May 1;12(3):203-12.\u003c/li\u003e\n\u003cli\u003eBhadra D, Shah NC, Rao AS, Dedania MS, Bajpai N. A 1-year comparative evaluation of clinical performance of nanohybrid composite with Activa\u0026trade; bioactive composite in Class II carious lesion: A randomized control study. Journal of Conservative Dentistry and Endodontics. 2019 Jan 1;22(1):92-6.\u003c/li\u003e\n\u003cli\u003eAlrahlah A. Diametral tensile strength, flexural strength, and surface microhardness of bioactive bulk fill restorative. J contemp dent pract. 2018 Jan 1;19(1):13-9.\u003c/li\u003e\n\u003cli\u003eBishnoi N, de Ataide ID, Fernandes M, Lambor DR, Sandhu B. Evaluating the marginal seal of a bioactive restorative material activa bioactive and two bulk fill composites in class II restorations: an in vitro study. Int J Appl Dent Sci. 2020;6(3):98-102.\u003c/li\u003e\n\u003cli\u003eAbdel-Karim UM, El-Eraky M, Etman WM. Three-year clinical evaluation of two nano-hybrid giomer restorative composites. Tanta Dental Journal. 2014 Dec 1;11(3):213-22.\u003c/li\u003e\n\u003cli\u003eVaid DS, Shah NC, Bilgi PS. One year comparative clinical evaluation of EQUIA with resin-modified glass ionomer and a nanohybrid composite in noncarious cervical lesions. Journal of Conservative Dentistry and Endodontics. 2015 Nov 1;18(6):449-52.\u003c/li\u003e\n\u003cli\u003eOzer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five‐year clinical performance of two fluoride‐releasing giomer resin materials in occlusal restorations. Journal of Esthetic and Restorative Dentistry. 2022 Dec;34(8):1213-20.\u003c/li\u003e\n\u003cli\u003eGaroushi S, Vallittu PK, Lassila L. Characterization of fluoride releasing restorative dental materials. Dental Materials Journal. 2018 Mar 26;37(2):293-300.\u003c/li\u003e\n\u003cli\u003eIslam MS, Nassar M, Elsayed MA, Jameel DB, Ahmad TT, Rahman MM. In vitro optical and physical stability of resin composite materials with different filler characteristics. Polymers. 2023 Apr 29;15(9):2121.\u003c/li\u003e\n\u003cli\u003eJyothi KN, Annapurna S, Kumar AS, Venugopal P, Jayashankara CM. Clinical evaluation of giomer-and resin-modified glass ionomer cement in class V noncarious cervical lesions: An: in vivo: study. Journal of Conservative Dentistry. 2011 Oct 1;14(4):409-13.\u003c/li\u003e\n\u003cli\u003eKaptan A, Oznurhan F, Candan M. In vitro comparison of surface roughness, flexural, and microtensile strength of various glass-ionomer-based materials and a new alkasite restorative material. Polymers. 2023 Jan 27;15(3):650.\u003c/li\u003e\n\u003cli\u003eMart\u0026iacute;nez-Sabio L, Pe\u0026ntilde;ate L, Arregui M, Veloso Duran A, Blanco JR, Guinot F. Comparison of shear bond strength and microleakage between activa\u0026trade; bioactive restorative\u0026trade; and bulk-fill composites\u0026mdash;An in vitro study. Polymers. 2023 Jun 27;15(13):2840.\u003c/li\u003e\n\u003cli\u003eRadwanski M, Zmyslowska-Polakowska E, Osica K, Krasowski M, Sauro S, Hardan L, Lukomska-Szymanska M. Mechanical properties of modern restorative \u0026ldquo;bioactive\u0026rdquo; dental materials-an in vitro study. Scientific Reports. 2025 Jan 28;15(1):3552.\u003c/li\u003e\n\u003cli\u003eEl-Gaaly AN, Hassan RR, Shaalan OO. Clinical evaluation of new bioactive restorative material versus resin modified glass ionomer in restoration of cervical carious lesions: Randomized clinical trial. Advanced Dental Journal. 2024 Apr 1;6(2):339-49.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Giomer technology, S-PRG, Beautifil flow, Smart bioactive, ACTIVA bioactive, Injectable composite, Clinical performance","lastPublishedDoi":"10.21203/rs.3.rs-6237005/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6237005/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eBioactive materials can stop caries progression through releasing fluoride. The challenge in restoring cervical cavities is the dentin in the cervical margin where the high organic content and fluid movement in dentinal tubules make it a complicated structure. This study was carried out to evaluate the clinical performance of two different bioactive injectable flowable resin composite materials in restoring class V cavities over 18 months.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThirty four participants with class V carious lesions were enrolled randomly. The participants were assigned into two groups (n\u0026thinsp;=\u0026thinsp;17): Group (1) Beautifil Flow Plus X. Group (2) ACTIVA bioactive restorative. The modified USPHS criteria were used to evaluate ehe restorations at baseline as well as after 6, 12 and 18 months. Categorical data was described as frequency and percentage, the Chi-Squared test was used for intragroup comparisons between intervention and comparator while Cochran\u0026rsquo;s Q test was used for intragroup comparison in each group followed by multiple comparisons.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThere was no statistically significant difference in the intergroup comparisons in all the USBH criteria that was evaluated. Both groups revealed statistically significant differences in surface texture and anatomical form over different follow-up periods.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eBoth Beautifil flow plus X and ACTIVA bioactive have acceptable clinical performance in class V cavities after 18 months follow up period.\u003c/p\u003e\u003ch2\u003eClinical Significance:\u003c/h2\u003e \u003cp\u003eBeautifil Flow Plus X injectable composite could be a promising material for restoring cervical cavities.\u003c/p\u003e\u003ch2\u003eClinical trial registration:\u003c/h2\u003e \u003cp\u003eThe trial was registered retrospectively on (15/07/2022) at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://clinicaltrials.gov\u003c/span\u003e\u003cspan address=\"https://clinicaltrials.gov\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e with the ID (NCT05466461).\u003c/p\u003e","manuscriptTitle":"Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities: An 18 month Randomized Clinical Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-15 00:16:37","doi":"10.21203/rs.3.rs-6237005/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"29dd0a26-9467-4f1f-a53b-18d7b390e39d","owner":[],"postedDate":"April 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-07-17T04:38:36+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-15 00:16:37","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6237005","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6237005","identity":"rs-6237005","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}