Performance of Nitric acid and Mineral Enriched System Versus Phosphoric Acid and Universal Adhesive in cervical carious lesions: a randomized clinical trial

Performance of Nitric acid and Mineral Enriched System Versus Phosphoric Acid and Universal Adhesive in cervical carious lesions: a 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 Performance of Nitric acid and Mineral Enriched System Versus Phosphoric Acid and Universal Adhesive in cervical carious lesions: a randomized clinical trial Nourane Yasser Ali, Dina Ezzeldin Mohamed, Olfat Elsayed Hassanein This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6088218/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: Phosphoric acid is considered the most commonly used acid for the pretreatment of tooth structures prior to resin composite restoration. However, its use on dentin substrates is frequently associated with postoperative sensitivity. Therefore, this study aimed to evaluate the clinical performance of a multifunctional protocol comprising a nitric acid etch, mineral-enriched adhesive, and flowable composite liner compared with a conventional protocol using phosphoric acid, a universal adhesive, and a regular flowable composite liner in cervical carious anterior cavities. Methods: A total of 26 individuals presenting with 44 cervical anterior carious lesions were recruited and randomized into two equal groups. One group received treatment with a nitric acid etch (Clean and Boost dentin enamel cleanser, Vista Apex, USA) in conjunction with a mineral-enriched adhesive and a flowable composite liner (RE-GEN, Vista Apex, USA). The other group received treatment with phosphoric acid (Scotchbond Universal Etchant, 3M ESPE), a universal adhesive (Single Bond Universal Adhesive, 3M ESPE) , and a regular flowable composite liner (Filtek Supreme, 3M ESPE) . Both groups received a final restoration using a packable nanohybrid resin composite (Filtek Z350XT, 3M ESPE) . Postoperative sensitivity was evaluated using a visual analog scale at baseline, 6, and 12 months. The data was statistically analyzed using the Chi-Squared test with a statistical significance level set at (P ≤ 0.05). Intragroup comparisons for each intervention were performed using Cochran's Q test, with a statistical significance level set at (P ≤ 0.0083) after Bonferroni correction. Success rates were compared using the Z test for independent proportions, and relative risk was calculated to assess clinical significance. All tests were two-tailed, with a confidence level of 95% and a study power of 80%. Results: After 12 months, the risk of postoperative sensitivity was 44% lower in the nitric acid group compared to the phosphoric acid group (RR= 0.5625, 95%CI (0.3201 to 0.9884); P = 0.0454). The success rate for the phosphoric acid protocol was 27.3%, whereas the nitric acid protocol achieved a success rate of 59.1%, with a statistically significant difference (P = 0.0353). Conclusion: The use of nitric acid combined with mineral-enriched adhesive and a flowable composite liner system is a promising approach to reducing postoperative sensitivity. Trial registration: This study was registered at www.clinicaltrials.gov under the identification number NCT05928533 on 26/06/2023. Acid etch Adhesive Clean & Boost Cleanser Flowable Mineral-enriched Nitric acid Postoperative sensitivity RE-GEN Figures Figure 1 Figure 2 Figure 3 Figure 4 Background Dental composite is regarded as a significant advancement in Aesthetic and Conservative Dentistry. The adhesive properties with enamel and dentin facilitate the preservation of intact tooth structure, optimal aesthetics, and enhanced mechanical properties [1,2]. It is placed in 95% of anterior and 50% of posterior teeth as a direct restoration [ 3 ]. The annual failure rate of composite restorations is 1–5% for anterior teeth and 1–3% for posterior teeth [ 4 ]. This failure can be attributed to several challenges, such as the technique sensitivity of its placement, polymerization shrinkage, type and design of the cavity, tooth location, adhesive materials used, and operator- and patient-related factors. Although certain factors can be managed, others persist as inherent challenges [ 5 ]. A systematic review published in 2010 identified common reasons for composite failure in cervical restorations, including loss of retention, marginal discoloration accompanied by marginal deterioration, which can lead to secondary caries, and postoperative sensitivity [ 6 ]. The restoration of cervical carious lesions poses a considerable challenge for restorative dentists, attributed to complex clinical conditions that encompass difficult isolation, variation in tooth substrates, and intraoral biomechanical issues. Numerous modifications to resin composite materials and application techniques have been implemented and continue to be developed to address the aforementioned challenges. The smear layer is an unstable structure that affects the chemical and mechanical bonding between the restoration and tooth structure. Different techniques to manage the smear layer include its complete removal, modification, or dissolution. The traditional technique for preparing the tooth substrate for resin composite restoration involved the complete removal of this layer using 35–37% phosphoric acid. However, postoperative sensitivity was recurring issue reported by patients. A selective enamel etching technique was developed to address this issue by applying phosphoric acid exclusively to the enamel margins, followed by the application of a universal adhesive, also known as a multimode adhesive, to the entire prepared tooth structure. This type of adhesive includes a mild acidic monomer to fulfill the purpose of dentin conditioning. However, subsequent research has demonstrated that the clinical performance of multimode adhesives is superior when used in the etch-and-rinse mode compared to the self-etch mode [ 7 ]. Additionally, a commercial product has been developed to address the tooth substrate through an alternative method: the multifunction nitric acid etch [ 8 ]. It contains acid, which facilitates etching and cauterizes minor bleeding; isopropyl alcohol, serving as an antibacterial agent and surface cleaner prior to bonding; and Hydroxyethyl methacrylate (HEMA) is a desensitizer that blocks the dentinal tubules to reduce the sensitivity [ 9 ]. Another factor that may enhance the performance of restorative systems is the incorporation of bioactive properties. The concept of bioactivity in dentistry involves using materials that interact with surrounding tissues to produce a beneficial biological response or release active substances that encourage remineralization, improve tissue health and regeneration, and extend the longevity of the restoration. Bioactivity was first introduced in the field of dentistry by Larry Hench in 1960. Bioactive materials possess various properties, including inhibiting bacterial growth by releasing calcium, sodium, silica, and phosphate ions, as well as osteogenic properties attributed to calcium phosphate or tricalcium phosphate [ 10 ]. Limited trials have examined the impact of bioactive materials in restorative dentistry on biological, aesthetic, and mechanical performance [ 11 , 12 ]. The literature review indicated a lack of clinical trials examining the efficacy of multifunction nitric acid etch in conjunction with the mineral-enriched adhesive and flowable resin composite. Therefore, this study assessed the performance of nitric acid etch with the mineral-enriched adhesive and flowable resin composite compared with phosphoric acid with universal adhesive and regular flowable composite. The null hypothesis tested stated that there is no difference between the two systems used. Methods Study Setting and Design: The study was conducted at the Conservative Dentistry Department Outpatient Clinic, Faculty of Dentistry, Cairo University, from July 2023 to December 2024. The principal researcher (N.Y) carried out all activities associated with the research project, including explaining and performing the procedures to the Participants. The trial was designed as a two-armed, triple-blind, involving participants, assessors, and data analyzers, with a 1:1 allocation ratio. The trial is registered in the clinical trial registry site ( www.clinicaltrials.gov ) under the identification number ( NCT05928533 on 26/06/2023). All required application forms, checklists, and informed consent documents were submitted to and approved by the Research Ethics Committee (REC) Faculty of Dentistry, Cairo University. These documents were subsequently submitted to the REC for approval to mitigate any ethical issues or potential harm to participants during the study. The study received approval and was assigned an ID number (11/7/23). The study was reported in accordance with CONSORT guidelines. Sample size calculation: A power analysis was conducted to ensure adequate power for statistical tests of the research hypothesis, comparing nitric acid and mineral-enriched adhesive with phosphoric acid and universal adhesive regarding postoperative sensitivity for cervical restorations after one year. The findings of Corral et al. [ 13 ] indicate that the VAS in the phosphoric acid group after 12 months exhibited a general distribution with a standard deviation of 1.11. The observed difference between the experimental and control means was 1, with a Cohen's d effect size of 0.9. To reject the null hypothesis that the population means of the experimental and control groups are equal with a power of 0.8, a sample size of 17 teeth per group was required. The Type I error probability associated with this test of this null hypothesis was 0.05. The sample size was increased by 30% to account for potential dropouts, resulting in 22 per group. The sample size was calculated using PS Power and Sample for Windows version 3.1.6 using an independent t-test. Eligibility criteria: All participants were enrolled according to the settled eligibility criteria in general and for the teeth in specific, as presented in Table (1). Table 1 Eligibility criteria [ 14 , 15 ] Eligibility Criteria for Participants Inclusion criteria Exclusion criteria • Cervical carious anterior lesions. • Age: (20-45Ys). • Moderate caries risk patient. • Participants with poor oral hygiene. • Presence of para-functional habits. • Systemic diseases. • Lack of compliance. • Rampant caries. • Xerostomia. Eligibility Criteria for Teeth Inclusion criteria Exclusion criteria • Cervical carious lesion. (ICDAS score 4, Nyvad score three active lesions). • According to the UNC dentin sclerosis scale, the sclerosis index is zero or one [ 7 ]. • Vital teeth. • Normal occlusion. • Accessible isolation. • Gingival margin of the lesion should be within the enamel. • VAS from 4–6 • Pulpitis. • Endodontically treated teeth. • Abnormal occlusion. • Teeth mobility. • Severe or chronic periodontitis. • Root Caries. Recruitment, Randomization, and Allocation Concealment: A total of 32 patients were screened for eligibility, of which 26 met the study's inclusion criteria. The remaining patients did not satisfy the criteria required for participation in the study and thus were excluded. Twenty-six participants underwent a comprehensive examination and diagnosis. A total of 44 cervical carious lesions were allocated, with a maximum of two lesions per participant. After identifying potentially eligible participants for this study, the principal researcher provided a detailed explanation of the study and assessed the patients' interest in participation. The patient signed an informed consent form indicating approval for all the procedures and his/her acceptance to participate in this trial. Randomization was done using simple randomization by (D.E.) with computerized sequence generation using www.random.org , generating numbers from 1:44 organized into two columns, with the lesion serving as the randomization unit. The randomization list was kept secure to ensure no tampering with the random list. (O.H.) generated the random allocation sequence, and assigned the intervention/ comparator identification procedures to respective teeth. Each participant selected an opaque sealed envelope that contained the random allocation. Each envelope was signed, and the corresponding number was documented in the patient chart to ensure proper assignment. Participants preparation: Following the final and consent approval, the main researcher conducted a preparatory visit, including removing soft or hard deposits from the teeth. A thorough examination of all risk factors associated with caries occurrence was performed to formulate a strategy for participants to enhance their oral hygiene and reduce any conditions that could jeopardize the study's outcome. The included tooth sensitivity was evaluated based on the established inclusion criteria (VAS 4–6). Field preparation: Field preparation involved administering local anesthesia (Artpharmadent 1:100,000 Articaine/epinephrine) to participants prior to lesion removal and preparation. A 330 bur (SS White, USA), measuring 0.8 mm in diameter and 1.6 mm in length, was utilized in a high-speed handpiece with air/water coolant to prepare class V cavity preparations featuring incisal and gingival margins in enamel. A suitable spoon excavator was employed to eliminate any soft caries (Dentsply, Switzerland). A yellow-coded tapered finishing stone (MANI, Japan) beveled all margins with a short 45 o angulation, except at the cervical margin. Sectional isolation was performed using suitable clamps from the second right to left premolar to better visualize the lesion with heavy sheets (Powder-free Latex Silk Blue Heavy Dental Dam, Sanctuary Health Company, Malaysia). Inversion and floss ligation were a part of the rubber dam application; a subgingival clamp was applied when necessary [ 14 ]. Application of Nitric Acid and Mineral Enriched System (Intervention): For the intervention group, a multifunction nitric acid etch (Clean and boost dentin and enamel cleanser, Vista apex) was applied in three steps: first, a flow-through brush tip delivered the cleanser to ensure complete saturation of the surface; second, the cleanser was agitated for 10 seconds; and third, the surface was rinsed thoroughly for another 10 seconds. A single coat of the mineral-enriched adhesive (RE-GEN universal adhesive, Vista Apex) was applied using a micro brush in a rubbing motion for 10 seconds. Then, it was air-thinned for an additional 10 seconds. The bioactive flowable composite (RE-GEN Bioactive flowable composite, Vista apex) was utilized as a liner on the bonded surfaces within the system. Then, the adhesive and flowable were co-cured to increase their bioactivity using a calibrated light curing system (Woodpecker Light Cure I Led, China) with an intensity of 1600 mW/ cm 2 for 20 seconds according to the manufacturer's instructions. Application of Phosphoric acid with regular adhesive and flowable System (Comparator): Phosphoric acid (Scotchbond Universal Etchant, 3M) was applied to enamel and dentin for 15 seconds. The surface was rinsed for 10 seconds and gently air dried to eliminate any excess moisture without desiccating the dentin structure. Two coats of universal adhesive (Scotchbond Universal adhesive, 3M) were actively applied with a micro brush for 20 seconds with a gentle air thinning in-between the two layers and after application to allow solvent evaporation and optimize the adhesive-tooth interaction. Bonded surfaces were light-cured for 20 seconds using the same curing unit [ 15 , 16 ]. A flowable composite (Filtek Supreme, 3M) was applied as a liner over the dentin substrate and subsequently light-cured for 20 seconds [ 17 ]. Final restoration for both groups: A nanohybrid resin composite ( Filtek Z350 XT, 3M) of appropriate shade was utilized to fill the cavities in one or two increments, depending on the size of each cavity. The buildup and sculpting were performed using the freehand technique in accordance with the tooth contour. Each restoration was finished using a red-coded tapered finishing stone (MANI, Japan) and the yellow one (MANI, Japan) in a high-speed handpiece under water spray. The sequence of aluminum oxide finishing discs (TOR VM, Alex Dent) was utilized in descending order in a low-speed handpiece as follows: Coarse (70–90µm), medium (40µm), fine (24µm), and super-fine (8µm) [ 14 , 17 ]. Polishing was optimized using impregnated Eve tips. One operator (N.Y.) completed all restorative steps for standardization. All materials, along with their commercial names and specifications, are presented in Table (2). Table 2 Materials’ name, specifications, composition, manufacturers, web site and LOT numbers Materials’ name Specifications Composition Manufacturer & Web site LOT number Clean and boost dentin and enamel cleanser Nitric acid 2-hydroxyethyl methacrylate (1–10%), Propan-2-ol (1–5%) and Nitric acid (0.5-3%). Vista Apex, USA https://www.vistaapex.com/ 071522 RE-GEN Universal adhesive Mineral enriched adhesive 2-Propenoic acid, 2-methyl-, (1-methylethylidene)bis[4,1- phenyleneoxy(2-hydroxy-3,1-propanediyl)] ester (15–40%), Ethyl alcohol (15–40%), Bis[2-[(2-methyl-1-oxoallyl)oxy]ethyl] dihydrogen benzene1,2,4,5-tetracarboxylate (10–30%), 2-hydroxyethyl methacrylate (10–30%), 10- Methacryloyloxydecyl dihydrogen phosphate (10-MDP) from (7–13%), Acetone (1–5%) and Benzoic acid, 4-(dimethylamino)-, ethyl ester Benzoic acid, 4-(dimethylamino)-, ethyl ester (0.5–1.5%). Vista Apex, USA https://www.vistaapex.com/ 20223343 RE-GEN Bioactive Flowable Composite Bioactive flowable composite Barium glass (40–80%), 2-Propenoic acid, 2-methyl-, (1-methylethylidene) bis [4,1- phenyleneoxy(2-hydroxy-3,1-propanediyl)] ester (10–40%), Triethylene glycol dimethacrylate (10–30%), Submicron Silica (1–15%) and Benzoic acid, 4-(dimethylamino)- with ethyl ester (0–2%). Vista Apex, USA https://www.vistaapex.com/ 20223055 Scotchbond Universal Etchant Phosphoric acid etchant 34% phosphoric acid by weight and has a pH of approximately 0.1. The viscosity of the phosphoric acid gel etchant is modified with fumed silica and a water-soluble polymer. 3M ESPE, USA https://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/ 19312001 Scotchbond Universal adhesive Universal adhesive MDP Phosphate Monomer, Dimethacrylate resins, HEMA, Vitrebond™ Copolymer, Filler, Ethanol, Water, Initiators and Silane. 3M ESPE, USA https://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/ 30720A Filtek Supreme Flowable Restorative Nanofilled flowable composite Procrylat, BisGMA, and TEGDMA resins. The fillers are a combination of a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles) and ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 µm. The aggregate has an average cluster particle size of 0.6 to 10 µm. The total inorganic filler loading is approximately 65% by weight (46% by volume). 3M ESPE, USA https://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/ 10139439 Filtek Z350 XT Nanohybrid packable composite Combination of aggregated zirconia/silica cluster with primary particle size (5–20 nm), and non agglomerated silica filer (20 nm) & 78.5 Wt%. The organic matrix composes of Bis-GMA, UDMA, TEGDMA and Bis-EMA. 3M ESPE, USA https://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/ NG16860 Postoperative sensitivity assessment: D.E., as a second researcher blinded to the allocation sequence, evaluated the postoperative sensitivity using the visual analog scale. It is a horizontal line of 10 digits from 0 to 10 cm. The digit 0 indicates no pain, while the digit 10 indicates severe pain. It was assessed at 24 hours and after 6 and 12 months from restoration placement, as shown in the CONSORT 2010 Flow Diagram (Fig. 1). Each participant was subjected to evaporative and thermal stimuli. An air syringe from a conventional dental unit was used for evaporative sensitivity, positioned approximately 5 mm from the tooth surface. The air temperature was 25˚C ± 3˚C at pressure 0.5N/mm2 [ 18 ]. The duration of the air blast ranged from 1–5 seconds, as reported by the participants. The stimulus was stopped when the participants reported pain and pain intensity was recorded. The thermal stimuli were evaluated using an anesthetic carpule stored in a refrigerator at 4°C for at least 24 hours until it became ice; it was then removed immediately before testing. For thermal sensitivity assessment, the carpule was placed centrally on the tooth for 1–5 seconds, following the same protocol for evaporative testing. Participants indicated their sensitivity level on a 10-cm visual analog scale (VAS), and the highest reported response (whether from evaporative or thermal stimuli) was recorded as the overall sensitivity score. Postoperative sensitivity was classified as follows: no pain (VAS = 0), mild pain (VAS 1–3), moderate pain (VAS 4–6), and severe pain (VAS 7–10) [ 19 ]. Mild and moderate sensitivity did not necessitate restoration replacement, as these were managed with analgesic prescriptions [ 20 ]. Statistical analysis: Statistical analysis was conducted using Medcalc software, version 22 for Windows (Medcalc Software Ltd, Ostend, Belgium). The Shapiro-Wilk test was employed to assess the normality of continuous data. Continuous data showed non-parametric distribution, which was described using mean and standard deviation. Intergroup comparison of VAS values was performed using the Mann-Whitney test, while intragroup comparisons within each treatment group were conducted using the Friedman test, followed by multiple comparisons with a statistical significance level (P ≤ 0.05). Relative risk was used to assess the clinical significance. The success rate was compared using the Z test for independent proportions. The confidence limit was 95% with 80% power, and all tests were two-tailed. Results Demographic data: The mean age in the nitric acid group was 29.2 ± 7.1 years, whereas in the phosphoric acid group, it was 30.9 ± 8.3 years, with no significant difference between both groups (P = 0.567). Gender distribution indicated no significant difference between the two groups (P = 0.6256). In the intervention group, the male percentage was 23.1%, and the female percentage was 76.9%. In contrast, the control group exhibited male and female percentages of 15.4% and 84.6%, respectively. The distribution of teeth in both groups was as follows: maxillary incisors 45.5%, canines 22.7%, mandibular incisors 9.1%, and canines 22,7%, with no significant differences (P = 1.0000). Quantitative results: Intergroup comparisons revealed no significant difference in baseline VAS scores between the groups (P = 0.6438). However, at 24 hours, 6 months, and 12 months post-intervention, significant differences emerged (P < 0.05). Intragroup analyses showed that the nitric and phosphoric acid groups experienced significant changes in VAS scores over time (P < 0.00001). Intragroup comparison within Phosphoric acid has shown a significant difference between different follow-up periods (P < 0.00001) (Table 3 and Fig. 2). The median difference in VAS in the nitric acid group was − 3.5 (95% CI: -4.5- -3.0), while the mean reduction within the phosphoric acid group was − 3 (95% CI: -3.5 to -2.5). Table 3 Inter- and intragroup comparison among study groups at each follow-up Follow-up Phosphoric acid Nitric acid Min Max Median IQR Min Max Median IQR Before 2 9 5 a 3 to 6 1 8 4 a 3 to 6 24 hours 0 6 2 b 1 to 3 0 6 1 b 0 to 2 6 months 0 6 1 c 0 to 2 0 6 0 c 0 to 1 12 months 0 6 1 c 0 to 2 0 6 0 c 0 to 1 Means that do not share the same letter are statistically significant,* denotes statistical significance Categorical results: Intergroup comparisons revealed no significant difference before intervention (P = 0.7111). However, there was a significant difference at 24 hours, 6, and 12 months follow-up, there was a significant difference (P < 0.05). Within-group comparisons demonstrated significant improvement over time in both the nitric acid group (P < 0.001) and the phosphoric acid group (P = 0.008) (Table 4 and Fig. 3). The success rate was determined by considering "no pain" as success and categorizing mild, moderate, and severe pain as failure. After 12 months, the nitric acid protocol demonstrated a 44% lower risk of postoperative sensitivity than the phosphoric acid protocol RR = 0.5625(95%CI 0.3201 to 0.9884; P = 0.0454). Table 4 Frequency and percentage for postoperative sensitivity scores for the inter and intra-group comparison within each follow-up Follow-up Phosphoric acid Nitric acid P value No pain Mild Moderate Severe No pain Mild Moderate Severe Before 0(0%) 7(31.8%) 10(45.5%) 5(22.7%) 0(0%) 7(31.8%) 12(54.5%) 3(13.6%) P = 0.7111 24 hours 3(13.6%) 14(63.6%) 5(22.7%) 0(0%) 7(31.8%) 14(63.6%) 1(4.5%) 0(0%) P = 0.0431* 6 months 6(27.3%) 12(54.5%) 4(18.2%) 0(0%) 13(59.1%) 8(36.4%) 1(4.5%) 0(0%) P = 0.0237* 12 months 6(27.3%) 12(54.5%) 4 18.2%) 0(0%) 13(59.1%) 8(36.4%) 1(4.5%) 0(0%) P = 0.0237* P value P = 0.008* P < 0.001* Success rate: Phosphoric acid has shown a 27.3% success rate, while nitric acid has shown a 59.1% success rate, and there was a significant difference between them (P = 0.0353). The success rate of nitric acid was 31.8% compared to phosphoric acid (95% CI 2.64–54.41%), as shown in Fig. 4. Discussion Cervical caries present one of dentistry's most challenging and complex restorative problems, affecting the facial and/or the lingual surface of posterior and anterior teeth [ 21 ]. The etiology of this lesion is complex and multifactorial; the dentist must identify and address the underlying cause prior to initiating the restorative procedure. These factors include long-term accumulation of dental plaque on the teeth, lack of proper oral hygiene, different gingival diseases, hormonal disturbance from pregnancy, exposure to some medications that affect salivary secretion, and finally, the demineralization of enamel due to high consumption of carbohydrates and sweets [ 22 ]. Cervical caries often affect both enamel and dentin, complicating restoration due to the absence of materials that bond effectively to both substrates. The risk of restoration failure increases by approximately 39% when both enamel and dentin are affected, in contrast to lesions confined to enamel. Moreover, many factors determine the success of restoring this condition, such as the amount of sclerotic dentin, which increases with aging, contamination of salivary and gingival fluids, and hypersensitive dentin. Postoperative sensitivity, particularly following acid-etching procedures, is a common complication that can significantly disrupt patients’ daily activities, reduce overall treatment satisfaction, and potentially compromise pulp vitality over time. Additionally, prolonged or severe sensitivity may contribute to decreased patient satisfaction and, in some cases, could potentially jeopardize pulp vitality over time. Therefore, the longevity of restored cervical cavities is primarily determined by the dentist's skills, methods of cavity preparation, adhesive system, restorative materials used, and the age of the participants [ 23 ]. The adhesive system plays a pivotal role in achieving durable cervical resin composite restorations by establishing intimate contact between the tooth structure and the composite. The primary role of the adhesive is to create an intimate contact between the tooth and the resin composite. Various adhesives have been developed, culminating in the multimode adhesive, applicable in both etch and rinse or self-etch modes. Nevertheless, the optimal bonding strategy that ensures the best clinical outcomes remains undetermined [ 24 ]. Each mode possesses distinct advantages and disadvantages. The etch and rinse mode represents the oldest and most widely employed adhesive technique in dentistry, utilizing phosphoric acid as an etching agent at a concentration of 35–37%. The application occurs on both enamel (15–30 seconds) and dentin (10–15 seconds), leading to demineralization of the enamel surface through the extraction of mineral content, particularly calcium and phosphate, resulting in a microscopically rough surface. The removal of the smear layer and smear plug from the dentin surface generates micropores that facilitate the penetration of the bonding agent, thereby creating a connection between the restoration and the tooth structure. This mode establishes a robust micromechanical bond with enamel and dentin. However, it elevates the risk of postoperative sensitivity, particularly when the dentin becomes etched [ 25 ]. In response to these limitations, the self-etch mode was introduced. This approach employs a self-etching primer that contains acidic monomers capable of simultaneously etching the enamel and priming the dentin. The induced demineralization was less aggressive than in etch and rinse mode, attributable to the application of a milder acid, which contributed to the preservation of dentin integrity. It decreases the postoperative sensitivity and the bond strength with enamel compared to the etch and rinse mode [ 26 ]. Numerous published articles and systematic reviews indicate that universal adhesives demonstrate superior clinical performance when applied in etch and rinse mode [ 7 , 17 , 24 ]. A novel concept has been introduced to improve bonding for both enamel and dentin, known as selective dentin etching. This technique involves applying phosphoric acid—either at a reduced concentration or for a shorter duration—or using alternative acids that produce favorable effects on the dentin substrate. Such modifications are intended to enhance adhesive-collagen interactions and establish a stable hybrid layer, partly due to the presence of 10-MDP monomer in the universal adhesive, which chemically bonds with calcium ions in hydroxyapatite crystals. This process reduces postoperative sensitivity by minimizing dentinal tubule exposure and fluid movement [ 27 ]. Historically, nitric acid was employed for etching both enamel and dentin in the late 1940s, although it was initially considered too aggressive because it caused excessive demineralization, rendering bonding unpredictable. Nevertheless, nitric acid has recently been reintroduced as an alternative etchant to phosphoric acid [ 28 ]. The mechanism of action of nitric acid as an etchant is distinct from that of phosphoric acid, as it involves chemical dissolution and surface modification. The application of nitric acid results in demineralization through the dissolution of calcium phosphate crystals in the enamel or dentin, thereby exposing the organic matrix. Additionally, it can interact with calcium ions to form calcium nitrate and hydroxide, which contribute to the sealing of dentinal tubules. The selective demineralization of the enamel surface using nitric acid facilitates the formation of a more porous surface, thereby enhancing the mechanical retention of the adhesive [ 29 ]. The advancements in dental technology have significantly enhanced the significance of tissue engineering. Tissue engineering combines life sciences with engineering principles to develop methods and materials aimed at repairing damaged or diseased tissue via tissue replacement [ 30 ]. The term bioactive in restorative dentistry refers to the ability of the material to induce a favorable biological reaction from the surrounding structures, release bioactive ingredients, and compose hydroxyapatite crystals on its surface [ 31 ]. One of the most widely recognized bioactive materials in dentistry is Bioglass 45S5, named for its composition of Bioglass, which is 45% silicon dioxide (SiO2), 24.5% sodium oxide (Na2O), 24.5% calcium oxide (CaO), and 6% phosphorus pentoxide (P2O5). Silicate-based glasses undergo degradation in body fluids, serving as a reservoir for ions essential for healing. Bioglass serves as an implant device in the human body for the replacement and repair of damaged bones due to its biocompatibility and bioactivity [ 32 , 33 ]. Sodium plays a key role in bioactivity by affecting the glass network; the degradation rate and subsequent apatite formation are strongly influenced by the connectivity of the silica network and the phosphate content. Fluoride is essential for constructing acid-resistant fluorapatite crystals rather than hydroxyapatite, and its conjugation with bioactive glass augments the remineralization process [ 32 ]. Using bioactive glass within the dental adhesives aims to enhance the bond strength and the longevity of dental composite restoration. Its high zinc content can protect the collagen matrix from degradation by matrix metalloproteinases (MMPs). Moreover, bioactive glass can reduce micro permeability by remineralizing demineralized areas and enhancing the modulus of elasticity and hardness of the adhesive interface. Additionally, it decreases micro permeability by remineralizing areas deficient in minerals and enhancing both the modulus of elasticity and hardness. This process reduces dentin hypersensitivity by occluding the dentinal tubules by binding them with collagen fibers and precipitating hydroxyapatite. Bioglasses are incorporated into restorative materials as a flowable resin composite to suppress the proliferation of oral bacteria such as Streptococcus mutans and E. coli while maintaining bond strength and enhancing adhesive bioactivity [ 34 ]. A review of the existing literature reveals a significant gap in clinical trials examining the effects of bioactive adhesives on postoperative sensitivity. A clinical trial conducted in 2002 was the sole relevant study identified, which investigated the bioactive system comprising S-PRG (Surface Pre-reacted Glass Ionomer) and its impact on postoperative sensitivity. This study's findings demonstrate that the bioactive system effectively reduces postoperative sensitivity, which is linked to the release of six key ions: sodium, boron, aluminum, silicon, strontium, and fluoride [ 35 ]. This study utilized nitric acid with a mineral-enriched adhesive and a flowable composite liner as the intervention arm. In contrast, the comparator arm used phosphoric acid and universal adhesive in etch and rinse mode with a nanofilled flowable composite frequently used as a restorative system. The manufacturer of a mineral-enriched system asserts that this protocol enhances bonding by attracting ions and protecting and healing substrate. Bioglass facilitates the attraction and exchange of bioactive ions (Ca2+, PO4 3-, F-) with the oral environment and tissue fluids, supported by continuous pH buffering. This mechanism aids in preventing erosion and secondary decay, contributing to the closure of marginal gaps and the preservation of marginal integrity. The current trial results indicate that nitric acid and mineral-enriched systems demonstrated higher postoperative sensitivity than phosphoric acid and standard restorative systems. The results presented in (Tables 3 , 4 , and Fig. 2,3), can be attributed to the HEMA content of the cleanser, which blocks dentin tubules and decreases the postoperative sensitivity. Furthermore, the effective bio-regenerative ability of the mineral-enriched system enhances interfacial remineralization and optimizes bonding quality, contributing to the reduction of postoperative sensitivity. Based on these results, the null hypothesis (which stated that there would be no difference between the two systems) was rejected, as a significant difference was found between the intervention and comparator groups. Although there is a paucity of clinical trials evaluating the performance of nitric acid and mineral-enriched systems, previous studies by Francis et al. (2020) and Javed et al. (2024) reported similar postoperative sensitivity outcomes between etch-and-rinse and self-etch modes. This finding contrasts with our results [ 36 , 37 ]. This discrepancy may be due to variations in the comparator groups; our study utilized a nitric acid-based bioactive system rather than a self-etch adhesive. One of the limitations of this study is the lack of an overall clinical assessment of both systems used, which is planned for publication following the completion of the minimum follow-up period according to USPHS guidelines. Furthermore, our research did not encompass a comprehensive assessment of the entire bioactive system in its full complexity. Future research should focus on a comprehensive evaluation of the complete bioactive system to elucidate all components' synergistic effects and overall performance. It is also important to note that this study focused on patients with moderate caries risk; high-risk patients may present unique challenges that exhibit distinct challenges that could affect treatment outcomes, indicating that our findings may not be applicable to that to that population. Conclusions According to the framework of this study, the following conclusions are drawn: Nitric acid and mineral-enriched systems demonstrate significant potential in managing postoperative sensitivity. Bioactive materials represent an emerging strategy for treating anterior cervical carious lesions, offering enhanced therapeutic outcomes in restorative dentistry. Recommendations : A long-term assessment of the clinical performance of nitric acid and its associated system is recommended. The combination of a final bioactive restorative material beside the mineral-enriched system used might be of clinical significance. Additional clinical trials are needed to assess postoperative sensitivity in diverse clinical scenarios, including variations in lesion depth, sclerosis degree, lesion type, tooth location (with differing functional demands), and other patient-related factors. Abbreviations VAS Visual analog scale HEMA Hydroxyethyl Methacrylate E. Coli Escherichia coli IQR Interquartile Range Declarations Acknowledgements: We would like to thank Professor Asmaa Yassin for her scientific support and guidance during this study. Her assistance in the Department of Conservative Dentistry at the Faculty of Dentistry, Cairo University, was invaluable. We appreciate her commitment to our research. Thank you, Professor Yassin, for your support. Disclosure statement: The authors declare that they have no conflict of interest. Author contributions: N.Y, O.H and D.E participated in designing the study. D.E participated in generating the data. O.H did the allocation concealment. N.Y performed all the practical steps and acting as main researcher and corresponding author. D.E assessed the outcome of the study. N.Y wrote the manuscript. O.H and D.E revised the final version of the manuscript. Funding: This article was fully funded by the researchers. Data availability: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. Ethics approval and consent to participate This study was approved by the Research Ethical Committee at Faculty of Dentistry, Cairo University with number 11/7/23. This randomized clinical trial study was conducted at the Faculty of Dentistry - Cairo University following the ethical principles of the World Medical Association Declaration of Helsinki. All patients were informed of the goals and procedures of the trial before consenting to participate and signing the informed consent form. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Author Details Nourane Yasser Ali (N.Y) (corresponding author): PhD candidate, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt and Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Egyptian Russian University, Egypt. Email: [email protected] ORCID: (0009-0002-7240-1324) Dina Ezz (D.E): Lecturer of Conservative Dentistry, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. Email: [email protected] ORCID:(0000-0002-7178-1065) Olfat El Sayed Hassanein (O.H): Professor of Conservative Dentistry, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. Email: [email protected] ORCID: (0009-0006-6269-5866) References Kolus T, Ucar AY. A systematic review and meta-analysis of the success of resin composite restorations. J Adv Oral Res. 2022;13:157–66. 2, Munchow EA, Bottino MC. Dental adhesives: from earlier products to bioactive and smart materials. In: Mittal KL, Etziler FM, editors. Adhesion in pharmaceutical biomedical and dental fields.1st edition. Wiley-Scrivener;2017. pp. 331–368. Nicholson J, Czarnecka B. Composite resins. In: Laura Overend, editor. Materials for the Direct Restoration of Teeth. 1st edition. Cambridge: Matthew Deans;2016. pp. 37–67. Dermarco FF, Collares K, Correa MB, Cenci MS, Moraes RR, Opdam NJ. Should my composite restorations last forever? Why are they failing? Dent Mater J. 2017;31:92–9. Albelasy EH, Hamama HH, Chew HP, Montaser M, Mahmoud SH. Secondary caries and marginal adaptation of ion releasing versus resin composite restorations: a systematic review and meta-analysis of randomized clinical trials. Sci Rep. 2022;12:1–17. Heintze SD, Ruffieux C, Rousson V. Clinical performance of cervical restorations—A meta-analysis. Dent Mater. 2010;26(10):993–1000. Perdigao J, Ceballos L, Giraldez I, Baracco B, Fuentes M. Effect of a hydrophobic bonding resin on the 36-month performance of a universal adhesive- a randomized clinical trial. Clin Oral Investig. 2020;24:765–76. Stape THS, Wik P, Mutulay MM, Al ani AAS, Mutulay AT. Selective dentin etching: a potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018;86:14–22. Risnes S, Li C. On the method of revealing enamel structure by acid etching. Aspects of optimization and interpretation. Microsc Res Tech. 2019;82:1668–80. Ladion LG, Bernal A, Calderon D, Cortes D. Bioactive materials in restorative dentistry: a literature review. SVOA Dent. 2021;4:74–81. Ferracane JL, Sidhu SK, Melo BDS, Yeo MAS, Diogenes ISL, Darvell A. BW. Bioactive dental materials: Developing, promising, confusing. JADA.2023; 2: 1–5. Özcan M, Garcia LDFR, Volpato CAM. Bioactive materials for direct and indirect restorations: concepts and applications. Front Dent Med. 2021;2:1–10. Coral C, Grez PV, Letelier M, Campos EA, Dourado AL, Fenandez E. Effect of oxalic acid–based desensitizing agent on cervical restorations on hypersensitive teeth: a triple-blind randomized controlled clinical trial. J Oral Facial Pain Headache. 2016;30:330–7. El morsy K, Abdalla AI, Shalaby ME. Clinical evaluation of three adhesive systems in class V carious lesions. Tanta dent j 2018, 15:132–9. Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020;24:1569–78. Zanatta RF, Silva TM, Esper M, Bersciani E, Goncaves S, Caneppele T. Bonding performance of simplified adhesive systems in non-carious lesions at 2 years follow up: a double blind randomized clinical trial. J Oper Dent. 2019;44:476–87. Oz FD, Kutuk ZB, Ozturk C, Soleimani R, Gurgan S. An 18-month clinical evaluation of three different universal adhesives with a universal flowable composite resin in the restoration of non-carious cervical lesions. Clin Oral Investig. 2019;23:1443–52. Hall C, Mason S, Cooke J. Exploratory randomized controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017;60:36–43. Otakhoigbogie U, Osagbemiro BB, Egwim IC. A comparison of three pain assessment scales in the assessment of pain among dental patients in Port Harcourt. Eur J Med Health Sci. 2020;2(4):1–4. Maghaireh GA, Albashaireh ZS, Allouz HA. Postoperative sensitivity in posterior restorations restored with self-adhesive and conventional bulk-fill resin composites: A randomized clinical split-mouth trial. J Dent. 2023;137:1–7. Zabeu GS, Mosquim V, Bastos NA, Sntin DC, Agulhari MAS, Wang L. Dental cervical lesions: how the etiologies imply in different approaches for long lasting performance. Arch Health Investig. 2022;11(1):125–33. Stewardson D, Thornley P, Bigg T, Bromage C, Browne A, Cottam D, Dalby D, Gilmour J, Horton J, Roberts E, Westoby L, Dietrich T, Burke T. The survival of Class V restorations in general dental practice. Br Dent J. 2012;212:1–9. Kubo S. Longevity of resin composite restorations. J Dent Sci. 2011;47:43–55. Hong X, Huang Z, Tong Z, Jiang H, Su M. Clinical effects of different etching modes for universal adhesives: a systematic review and meta-analysis. Ann Palliat Med. 2021;10(5):5462–73. Pashley DH, Tay FR, Breschi L, Tjäderhane L, Carvalho RM, Carrilho M, Mutluay AT. State of the art etch-and-rinse adhesives. Dent Mater J. 2011;27(1):1–34. Yousaf A, Aman N, Manzoor MA, Shah JA, Dilrasheed. Postoperative sensitivity of self etch versus total etch adhesive. J Coll Physicians Surg Pak. 2014;24(6):383–6. Stape THS, Wik P, Mutluay MM, Al-Ani AAS, Mutluay AT. Selective dentin etching: a potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018:1–30. Blosser RL. Time dependence of 2.5% nitric acid solution as an etchant on human dentin and enamel. Dent Mater J. 1990;6:83–7. Risnes S, Li C. On the method of revealing enamel structure by acid etching. Aspects of optimization and interpretation. Microsc Res Tech. 2019;82:1668–80. Zafar MS, Khurshid Z, Almas K. Oral tissue engineering progress and challenges. J Tissue Eng Regen Med. 2015;12(6):387–97. Baino F, Hamzehlou S, Kargozar S. Bioactive glasses: where are we and where are we going? J Funct Biomater. 2018;9:1–26. Skallevold HE, Rokaya D, Khurshid Z, Zafar MS. Bioactive glass application in dentistry. Int J Mol Sci. 2019;20:1–24. Mai S, Zhang Q, Liao M, Ma X, Zhong Y. Recent advances in direct adhesive restoration resin based dental materials with remineralizing agents. Front Dent Med. 2022;3:1–9. Ali S, Farooq I, Iqbal K. A review of the effect of various ions on the properties and the clinical applications of novel bioactive glasses in medicine and dentistry. Saudi Dent J. 2014;26:1–5. Gordan VV, Mjör IA. Short- and long-term clinical evaluation of post-operative sensitivity of a new resin-based restorative material and self-etching primer. Oper Dent. 2002;27(6):543–8. Francis T, Sakkir N, Soe HHK, Yeow TY, Hwe HZ, Tze ALM. Postoperative sensitivity of selective-etch and total-etch techniques in composite resin restorations: an in vivo study. JCDR. 2020;14(4):1–4. Javed K, Noor N, Nasir MZ, Manzoor MA. Comparison of postoperative hypersensitivity between total-etch and universal adhesive system: a randomized clinical trial. Sci Rep. 2024;14:1–6. Additional Declarations No competing interests reported. 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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-6088218","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":437653273,"identity":"5acb479a-b7dc-46e6-b2d2-7676183c37d2","order_by":0,"name":"Nourane Yasser Ali","email":"","orcid":"","institution":"Cairo University","correspondingAuthor":false,"prefix":"","firstName":"Nourane","middleName":"Yasser","lastName":"Ali","suffix":""},{"id":437653274,"identity":"03c719f2-986a-4f73-b503-87d46b3338d6","order_by":1,"name":"Dina Ezzeldin Mohamed","email":"data:image/png;base64,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","orcid":"","institution":"Cairo University","correspondingAuthor":true,"prefix":"","firstName":"Dina","middleName":"Ezzeldin","lastName":"Mohamed","suffix":""},{"id":437653275,"identity":"1235a490-ba7c-4673-b7cd-17d6f94cd943","order_by":2,"name":"Olfat Elsayed Hassanein","email":"","orcid":"","institution":"Cairo University","correspondingAuthor":false,"prefix":"","firstName":"Olfat","middleName":"Elsayed","lastName":"Hassanein","suffix":""}],"badges":[],"createdAt":"2025-02-23 05:08:12","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6088218/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6088218/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":79890193,"identity":"cd0a6d78-153a-476e-b3e9-868a90a51e43","added_by":"auto","created_at":"2025-04-04 07:14:44","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":410987,"visible":true,"origin":"","legend":"\u003cp\u003eFlow Diagram (Consort 2010)\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6088218/v1/659907b0404973a9e693ba57.png"},{"id":79889606,"identity":"1940c831-75ec-44c3-a23b-30e570545b64","added_by":"auto","created_at":"2025-04-04 07:06:44","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":106033,"visible":true,"origin":"","legend":"\u003cp\u003eBox plot showing mean VAS within each material at different follow-up periods\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6088218/v1/82aa82d175f32f74cf9e9016.png"},{"id":79889612,"identity":"b579bcd9-1dc2-4491-b8dc-9f1566f34bec","added_by":"auto","created_at":"2025-04-04 07:06:44","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":172337,"visible":true,"origin":"","legend":"\u003cp\u003e100% stacked column chart showing percentage of hypersensitivity scores at different \u0026nbsp;follow-up periods\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6088218/v1/497ab108d23af1d2a113dc39.png"},{"id":79889609,"identity":"2ca4a024-290c-42af-96b8-12d6aed0ff34","added_by":"auto","created_at":"2025-04-04 07:06:44","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":169177,"visible":true,"origin":"","legend":"\u003cp\u003eLine chart showing change in percentage of participants having hypersensitivity through time\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-6088218/v1/2b65590f34dffec4cb40715c.png"},{"id":81230539,"identity":"1e5cd990-b109-4cff-a80a-18885826d1ff","added_by":"auto","created_at":"2025-04-23 17:31:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2355272,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6088218/v1/7c927667-caf0-4be4-a8b0-a5fc2ec2d50f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Performance of Nitric acid and Mineral Enriched System Versus Phosphoric Acid and Universal Adhesive in cervical carious lesions: a randomized clinical trial","fulltext":[{"header":"Background","content":"\u003cp\u003eDental composite is regarded as a significant advancement in Aesthetic and Conservative Dentistry. The adhesive properties with enamel and dentin facilitate the preservation of intact tooth structure, optimal aesthetics, and enhanced mechanical properties \u003cb\u003e[1,2].\u003c/b\u003e It is placed in 95% of anterior and 50% of posterior teeth as a direct restoration [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe annual failure rate of composite restorations is 1\u0026ndash;5% for anterior teeth and 1\u0026ndash;3% for posterior teeth [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. This failure can be attributed to several challenges, such as the technique sensitivity of its placement, polymerization shrinkage, type and design of the cavity, tooth location, adhesive materials used, and operator- and patient-related factors. Although certain factors can be managed, others persist as inherent challenges [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. A systematic review published in 2010 identified common reasons for composite failure in cervical restorations, including loss of retention, marginal discoloration accompanied by marginal deterioration, which can lead to secondary caries, and postoperative sensitivity [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The restoration of cervical carious lesions poses a considerable challenge for restorative dentists, attributed to complex clinical conditions that encompass difficult isolation, variation in tooth substrates, and intraoral biomechanical issues. Numerous modifications to resin composite materials and application techniques have been implemented and continue to be developed to address the aforementioned challenges.\u003c/p\u003e \u003cp\u003eThe smear layer is an unstable structure that affects the chemical and mechanical bonding between the restoration and tooth structure. Different techniques to manage the smear layer include its complete removal, modification, or dissolution. The traditional technique for preparing the tooth substrate for resin composite restoration involved the complete removal of this layer using 35\u0026ndash;37% phosphoric acid. However, postoperative sensitivity was recurring issue reported by patients. A selective enamel etching technique was developed to address this issue by applying phosphoric acid exclusively to the enamel margins, followed by the application of a universal adhesive, also known as a multimode adhesive, to the entire prepared tooth structure. This type of adhesive includes a mild acidic monomer to fulfill the purpose of dentin conditioning. However, subsequent research has demonstrated that the clinical performance of multimode adhesives is superior when used in the etch-and-rinse mode compared to the self-etch mode [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Additionally, a commercial product has been developed to address the tooth substrate through an alternative method: the multifunction nitric acid etch [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. It contains acid, which facilitates etching and cauterizes minor bleeding; isopropyl alcohol, serving as an antibacterial agent and surface cleaner prior to bonding; and Hydroxyethyl methacrylate (HEMA) is a desensitizer that blocks the dentinal tubules to reduce the sensitivity [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAnother factor that may enhance the performance of restorative systems is the incorporation of bioactive properties. The concept of bioactivity in dentistry involves using materials that interact with surrounding tissues to produce a beneficial biological response or release active substances that encourage remineralization, improve tissue health and regeneration, and extend the longevity of the restoration. Bioactivity was first introduced in the field of dentistry by Larry Hench in 1960. Bioactive materials possess various properties, including inhibiting bacterial growth by releasing calcium, sodium, silica, and phosphate ions, as well as osteogenic properties attributed to calcium phosphate or tricalcium phosphate [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Limited trials have examined the impact of bioactive materials in restorative dentistry on biological, aesthetic, and mechanical performance [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe literature review indicated a lack of clinical trials examining the efficacy of multifunction nitric acid etch in conjunction with the mineral-enriched adhesive and flowable resin composite. Therefore, this study assessed the performance of nitric acid etch with the mineral-enriched adhesive and flowable resin composite compared with phosphoric acid with universal adhesive and regular flowable composite. The null hypothesis tested stated that there is no difference between the two systems used.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eStudy Setting and Design:\u003c/h2\u003e\n \u003cp\u003eThe study was conducted at the Conservative Dentistry Department Outpatient Clinic, Faculty of Dentistry, Cairo University, from July 2023 to December 2024. The principal researcher (N.Y) carried out all activities associated with the research project, including explaining and performing the procedures to the Participants. The trial was designed as a two-armed, triple-blind, involving participants, assessors, and data analyzers, with a 1:1 allocation ratio. The trial is registered in the clinical trial registry site (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.clinicaltrials.gov\u003c/span\u003e\u003c/span\u003e) under the identification number (\u003cstrong\u003eNCT05928533\u003c/strong\u003e on \u003cstrong\u003e26/06/2023).\u003c/strong\u003e All required application forms, checklists, and informed consent documents were submitted to and approved by the Research Ethics Committee (REC) Faculty of Dentistry, Cairo University. These documents were subsequently submitted to the REC for approval to mitigate any ethical issues or potential harm to participants during the study. The study received approval and was assigned \u003cstrong\u003ean ID number (11/7/23).\u003c/strong\u003e The study was reported in accordance with CONSORT guidelines.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eSample size calculation:\u003c/h3\u003e\n\u003cp\u003eA power analysis was conducted to ensure adequate power for statistical tests of the research hypothesis, comparing nitric acid and mineral-enriched adhesive with phosphoric acid and universal adhesive regarding postoperative sensitivity for cervical restorations after one year. The findings of \u003cstrong\u003eCorral et al.\u003c/strong\u003e [\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e] indicate that the VAS in the phosphoric acid group after 12 months exhibited a general distribution with a standard deviation of 1.11. The observed difference between the experimental and control means was 1, with a Cohen\u0026apos;s d effect size of 0.9. To reject the null hypothesis that the population means of the experimental and control groups are equal with a power of 0.8, a sample size of 17 teeth per group was required. The Type I error probability associated with this test of this null hypothesis was 0.05. The sample size was increased by 30% to account for potential dropouts, resulting in 22 per group. The sample size was calculated using PS Power and Sample for Windows version 3.1.6 using an independent t-test.\u003c/p\u003e\n\u003ch3\u003eEligibility criteria:\u003c/h3\u003e\n\u003cp\u003eAll participants were enrolled according to the settled eligibility criteria in general and for the teeth in specific, as presented in Table\u0026nbsp;(1).\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eEligibility criteria [\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eEligibility Criteria for Participants\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eInclusion criteria\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eExclusion criteria\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026bull; Cervical carious anterior lesions.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Age: (20-45Ys).\u003c/p\u003e\n \u003cp\u003e\u0026bull; Moderate caries risk patient.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026bull; Participants with poor oral hygiene.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Presence of para-functional habits.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Systemic diseases.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Lack of compliance.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Rampant caries.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Xerostomia.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003eEligibility Criteria for Teeth\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026bull; Cervical carious lesion. (ICDAS score 4, Nyvad score three active lesions).\u003c/p\u003e\n \u003cp\u003e\u0026bull; According to the UNC dentin sclerosis scale, the sclerosis index is zero or one [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e\n \u003cp\u003e\u0026bull; Vital teeth.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Normal occlusion.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Accessible isolation.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Gingival margin of the lesion should be within the enamel.\u003c/p\u003e\n \u003cp\u003e\u0026bull; VAS from 4\u0026ndash;6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026bull; Pulpitis.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Endodontically treated teeth.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Abnormal occlusion.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Teeth mobility.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Severe or chronic periodontitis.\u003c/p\u003e\n \u003cp\u003e\u0026bull; Root Caries.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ch3\u003eRecruitment, Randomization, and Allocation Concealment:\u003c/h3\u003e\n\u003cp\u003eA total of 32 patients were screened for eligibility, of which 26 met the study\u0026apos;s inclusion criteria. The remaining patients did not satisfy the criteria required for participation in the study and thus were excluded. Twenty-six participants underwent a comprehensive examination and diagnosis. A total of 44 cervical carious lesions were allocated, with a maximum of two lesions per participant. After identifying potentially eligible participants for this study, the principal researcher provided a detailed explanation of the study and assessed the patients\u0026apos; interest in participation. The patient signed an informed consent form indicating approval for all the procedures and his/her acceptance to participate in this trial. Randomization was done using simple randomization by (D.E.) with computerized sequence generation using \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.random.org\u003c/span\u003e\u003c/span\u003e, generating numbers from 1:44 organized into two columns, with the lesion serving as the randomization unit. The randomization list was kept secure to ensure no tampering with the random list. (O.H.) generated the random allocation sequence, and assigned the intervention/ comparator identification procedures to respective teeth. Each participant selected an opaque sealed envelope that contained the random allocation. Each envelope was signed, and the corresponding number was documented in the patient chart to ensure proper assignment.\u003c/p\u003e\n\u003ch3\u003eParticipants preparation:\u003c/h3\u003e\n\u003cp\u003eFollowing the final and consent approval, the main researcher conducted a preparatory visit, including removing soft or hard deposits from the teeth. A thorough examination of all risk factors associated with caries occurrence was performed to formulate a strategy for participants to enhance their oral hygiene and reduce any conditions that could jeopardize the study\u0026apos;s outcome. The included tooth sensitivity was evaluated based on the established inclusion criteria (VAS 4\u0026ndash;6).\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eField preparation:\u003c/h2\u003e\n \u003cp\u003eField preparation involved administering local anesthesia (Artpharmadent 1:100,000 Articaine/epinephrine) to participants prior to lesion removal and preparation. A 330 bur (SS White, USA), measuring 0.8 mm in diameter and 1.6 mm in length, was utilized in a high-speed handpiece with air/water coolant to prepare class V cavity preparations featuring incisal and gingival margins in enamel. A suitable spoon excavator was employed to eliminate any soft caries (Dentsply, Switzerland). A yellow-coded tapered finishing stone (MANI, Japan) beveled all margins with a short 45\u003csup\u003eo\u003c/sup\u003e angulation, except at the cervical margin. Sectional isolation was performed using suitable clamps from the second right to left premolar to better visualize the lesion with heavy sheets (Powder-free Latex Silk Blue Heavy Dental Dam, Sanctuary Health Company, Malaysia). Inversion and floss ligation were a part of the rubber dam application; a subgingival clamp was applied when necessary [\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eApplication of Nitric Acid and Mineral Enriched System (Intervention):\u003c/h3\u003e\n\u003cp\u003eFor the intervention group, a multifunction nitric acid etch \u003cstrong\u003e(Clean and boost dentin and enamel cleanser, Vista apex)\u003c/strong\u003e was applied in three steps: first, a flow-through brush tip delivered the cleanser to ensure complete saturation of the surface; second, the cleanser was agitated for 10 seconds; and third, the surface was rinsed thoroughly for another 10 seconds. A single coat of the mineral-enriched adhesive \u003cstrong\u003e(RE-GEN universal adhesive, Vista Apex)\u003c/strong\u003e was applied using a micro brush in a rubbing motion for 10 seconds. Then, it was air-thinned for an additional 10 seconds. The bioactive flowable composite \u003cstrong\u003e(RE-GEN Bioactive flowable composite, Vista apex)\u003c/strong\u003e was utilized as a liner on the bonded surfaces within the system. Then, the adhesive and flowable were co-cured to increase their bioactivity using a calibrated light curing system (Woodpecker Light Cure I Led, China) with an intensity of 1600 mW/ cm\u003csup\u003e2\u003c/sup\u003e for 20 seconds according to the manufacturer\u0026apos;s instructions.\u003c/p\u003e\n\u003ch3\u003eApplication of Phosphoric acid with regular adhesive and flowable System (Comparator):\u003c/h3\u003e\n\u003cp\u003ePhosphoric acid \u003cstrong\u003e(Scotchbond Universal Etchant, 3M)\u003c/strong\u003e was applied to enamel and dentin for 15 seconds. The surface was rinsed for 10 seconds and gently air dried to eliminate any excess moisture without desiccating the dentin structure. Two coats of universal adhesive \u003cstrong\u003e(Scotchbond Universal adhesive, 3M)\u003c/strong\u003e were actively applied with a micro brush for 20 seconds with a gentle air thinning in-between the two layers and after application to allow solvent evaporation and optimize the adhesive-tooth interaction. Bonded surfaces were light-cured for 20 seconds using the same curing unit [\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e]. A flowable composite \u003cstrong\u003e(Filtek Supreme, 3M)\u003c/strong\u003e was applied as a liner over the dentin substrate and subsequently light-cured for 20 seconds [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eFinal restoration for both groups:\u003c/h2\u003e\n \u003cp\u003eA nanohybrid resin composite (\u003cstrong\u003eFiltek Z350 XT, 3M)\u003c/strong\u003e of appropriate shade was utilized to fill the cavities in one or two increments, depending on the size of each cavity. The buildup and sculpting were performed using the freehand technique in accordance with the tooth contour. Each restoration was finished using a red-coded tapered finishing stone (MANI, Japan) and the yellow one (MANI, Japan) in a high-speed handpiece under water spray. The sequence of aluminum oxide finishing discs (TOR VM, Alex Dent) was utilized in descending order in a low-speed handpiece as follows: Coarse (70\u0026ndash;90\u0026micro;m), medium (40\u0026micro;m), fine (24\u0026micro;m), and super-fine (8\u0026micro;m) [\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e]. Polishing was optimized using impregnated Eve tips. One operator (N.Y.) completed all restorative steps for standardization. All materials, along with their commercial names and specifications, are presented in Table (2).\u003c/p\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eMaterials\u0026rsquo; name, specifications, composition, manufacturers, web site and LOT numbers\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMaterials\u0026rsquo;\u003c/p\u003e\n \u003cp\u003ename\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSpecifications\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eComposition\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003eManufacturer\u003c/p\u003e\n \u003cp\u003e\u0026amp;\u003c/p\u003e\n \u003cp\u003eWeb site\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003eLOT number\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eClean and boost dentin and enamel cleanser\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNitric acid\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2-hydroxyethyl methacrylate (1\u0026ndash;10%), Propan-2-ol (1\u0026ndash;5%) and Nitric acid (0.5-3%).\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003eVista Apex, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.vistaapex.com/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e071522\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eRE-GEN Universal adhesive\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMineral enriched adhesive\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2-Propenoic acid, 2-methyl-, (1-methylethylidene)bis[4,1- phenyleneoxy(2-hydroxy-3,1-propanediyl)] ester (15\u0026ndash;40%), Ethyl alcohol (15\u0026ndash;40%), Bis[2-[(2-methyl-1-oxoallyl)oxy]ethyl] dihydrogen benzene1,2,4,5-tetracarboxylate (10\u0026ndash;30%), 2-hydroxyethyl methacrylate (10\u0026ndash;30%), 10- Methacryloyloxydecyl dihydrogen phosphate (10-MDP) from (7\u0026ndash;13%), Acetone (1\u0026ndash;5%) and Benzoic acid, 4-(dimethylamino)-, ethyl ester Benzoic acid, 4-(dimethylamino)-, ethyl ester (0.5\u0026ndash;1.5%).\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003eVista Apex, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.vistaapex.com/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e20223343\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eRE-GEN Bioactive Flowable Composite\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBioactive flowable composite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBarium glass (40\u0026ndash;80%), 2-Propenoic acid, 2-methyl-, (1-methylethylidene) bis [4,1- phenyleneoxy(2-hydroxy-3,1-propanediyl)] ester (10\u0026ndash;40%), Triethylene glycol dimethacrylate (10\u0026ndash;30%), Submicron Silica (1\u0026ndash;15%) and Benzoic acid, 4-(dimethylamino)- with ethyl ester (0\u0026ndash;2%).\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003eVista Apex, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.vistaapex.com/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e20223055\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eScotchbond Universal Etchant\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePhosphoric acid etchant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e34% phosphoric acid by weight and has a pH of approximately 0.1. The viscosity of the phosphoric acid gel etchant is modified with fumed silica and a water-soluble polymer.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003e3M ESPE, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e19312001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eScotchbond Universal adhesive\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUniversal adhesive\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMDP Phosphate Monomer, Dimethacrylate resins, HEMA, Vitrebond\u0026trade; Copolymer, Filler, Ethanol, Water, Initiators and Silane.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003e3M ESPE, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e30720A\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFiltek Supreme\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eFlowable Restorative\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNanofilled flowable composite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eProcrylat, BisGMA, and TEGDMA resins. The fillers are a combination of a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles) and ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 \u0026micro;m. The aggregate has an average cluster particle size of 0.6 to 10 \u0026micro;m. The total inorganic filler loading is approximately 65% by weight (46% by volume).\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003e3M ESPE, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003e10139439\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFiltek Z350 XT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNanohybrid packable composite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCombination of aggregated\u003c/p\u003e\n \u003cp\u003ezirconia/silica cluster with primary particle size (5\u0026ndash;20 nm), and\u003c/p\u003e\n \u003cp\u003enon agglomerated silica filer (20 nm) \u0026amp;\u003c/p\u003e\n \u003cp\u003e78.5 Wt%. The organic matrix composes of Bis-GMA, UDMA, TEGDMA and Bis-EMA.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 45.6918%;\"\u003e\n \u003cp\u003e3M ESPE, USA\u003c/p\u003e\n \u003cp\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.3mlietuva.lt/3M/lt_LT/p/d/b5005223013/\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 8.7468%;\"\u003e\n \u003cp\u003eNG16860\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003ePostoperative sensitivity assessment:\u003c/h2\u003e\n \u003cp\u003eD.E., as a second researcher blinded to the allocation sequence, evaluated the postoperative sensitivity using the visual analog scale. It is a horizontal line of 10 digits from 0 to 10 cm. The digit 0 indicates no pain, while the digit 10 indicates severe pain. It was assessed at 24 hours and after 6 and 12 months from restoration placement, as shown in the CONSORT 2010 Flow Diagram (Fig.\u0026nbsp;1). Each participant was subjected to evaporative and thermal stimuli. An air syringe from a conventional dental unit was used for evaporative sensitivity, positioned approximately 5 mm from the tooth surface. The air temperature was 25˚C\u0026thinsp;\u0026plusmn;\u0026thinsp;3˚C at pressure 0.5N/mm2 [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. The duration of the air blast ranged from 1\u0026ndash;5 seconds, as reported by the participants. The stimulus was stopped when the participants reported pain and pain intensity was recorded. The thermal stimuli were evaluated using an anesthetic carpule stored in a refrigerator at 4\u0026deg;C for at least 24 hours until it became ice; it was then removed immediately before testing. For thermal sensitivity assessment, the carpule was placed centrally on the tooth for 1\u0026ndash;5 seconds, following the same protocol for evaporative testing. Participants indicated their sensitivity level on a 10-cm visual analog scale (VAS), and the highest reported response (whether from evaporative or thermal stimuli) was recorded as the overall sensitivity score. Postoperative sensitivity was classified as follows: no pain (VAS\u0026thinsp;=\u0026thinsp;0), mild pain (VAS 1\u0026ndash;3), moderate pain (VAS 4\u0026ndash;6), and severe pain (VAS 7\u0026ndash;10) [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e]. Mild and moderate sensitivity did not necessitate restoration replacement, as these were managed with analgesic prescriptions [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical analysis:\u003c/h2\u003e\n \u003cp\u003eStatistical analysis was conducted using Medcalc software, version 22 for Windows (Medcalc Software Ltd, Ostend, Belgium). The Shapiro-Wilk test was employed to assess the normality of continuous data. Continuous data showed non-parametric distribution, which was described using mean and standard deviation. Intergroup comparison of VAS values was performed using the Mann-Whitney test, while intragroup comparisons within each treatment group were conducted using the Friedman test, followed by multiple comparisons with a statistical significance level (P\u0026thinsp;\u0026le;\u0026thinsp;0.05). Relative risk was used to assess the clinical significance. The success rate was compared using the Z test for independent proportions. The confidence limit was 95% with 80% power, and all tests were two-tailed.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eDemographic data:\u003c/h2\u003e \u003cp\u003eThe mean age in the nitric acid group was 29.2\u0026thinsp;\u0026plusmn;\u0026thinsp;7.1 years, whereas in the phosphoric acid group, it was 30.9\u0026thinsp;\u0026plusmn;\u0026thinsp;8.3 years, with no significant difference between both groups (P\u0026thinsp;=\u0026thinsp;0.567). Gender distribution indicated no significant difference between the two groups (P\u0026thinsp;=\u0026thinsp;0.6256). In the intervention group, the male percentage was 23.1%, and the female percentage was 76.9%. In contrast, the control group exhibited male and female percentages of 15.4% and 84.6%, respectively. The distribution of teeth in both groups was as follows: maxillary incisors 45.5%, canines 22.7%, mandibular incisors 9.1%, and canines 22,7%, with no significant differences (P\u0026thinsp;=\u0026thinsp;1.0000).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eQuantitative results:\u003c/h2\u003e \u003cp\u003eIntergroup comparisons revealed no significant difference in baseline VAS scores between the groups (P\u0026thinsp;=\u0026thinsp;0.6438). However, at 24 hours, 6 months, and 12 months post-intervention, significant differences emerged (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). Intragroup analyses showed that the nitric and phosphoric acid groups experienced significant changes in VAS scores over time (P\u0026thinsp;\u0026lt;\u0026thinsp;0.00001). Intragroup comparison within Phosphoric acid has shown a significant difference between different follow-up periods (P\u0026thinsp;\u0026lt;\u0026thinsp;0.00001) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and Fig.\u0026nbsp;2). The median difference in VAS in the nitric acid group was \u0026minus;\u0026thinsp;3.5 (95% CI: -4.5- -3.0), while the mean reduction within the phosphoric acid group was \u0026minus;\u0026thinsp;3 (95% CI: -3.5 to -2.5).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eInter- and intragroup comparison among study groups at each follow-up\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"9\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" 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 \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eFollow-up\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003ePhosphoric acid\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c9\" namest=\"c6\"\u003e \u003cp\u003eNitric acid\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBefore\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 to 6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e3 to 6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e24 hours\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 to 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0 to 2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6 months\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 to 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0 to 1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 to 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0 to 1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eMeans that do not share the same letter are statistically significant,* denotes statistical significance\u003c/h2\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003eCategorical results:\u003c/h2\u003e \u003cp\u003eIntergroup comparisons revealed no significant difference before intervention (P\u0026thinsp;=\u0026thinsp;0.7111). However, there was a significant difference at 24 hours, 6, and 12 months follow-up, there was a significant difference (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). Within-group comparisons demonstrated significant improvement over time in both the nitric acid group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and the phosphoric acid group (P\u0026thinsp;=\u0026thinsp;0.008) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and Fig.\u0026nbsp;3). The success rate was determined by considering \"no pain\" as success and categorizing mild, moderate, and severe pain as failure. After 12 months, the nitric acid protocol demonstrated a 44% lower risk of postoperative sensitivity than the phosphoric acid protocol RR\u0026thinsp;=\u0026thinsp;0.5625(95%CI 0.3201 to 0.9884; P\u0026thinsp;=\u0026thinsp;0.0454).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFrequency and percentage for postoperative sensitivity scores for the inter and intra-group comparison within each follow-up\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"10\"\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 \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eFollow-up\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003ePhosphoric acid\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c9\" namest=\"c6\"\u003e \u003cp\u003eNitric acid\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo pain\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMild\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eModerate\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSevere\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNo pain\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMild\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eModerate\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003eSevere\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBefore\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(31.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10(45.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5(22.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7(31.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e12(54.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e3(13.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eP\u0026thinsp;=\u0026thinsp;0.7111\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e24 hours\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(13.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14(63.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5(22.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7(31.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14(63.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1(4.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eP\u0026thinsp;=\u0026thinsp;0.0431*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6 months\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6(27.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12(54.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4(18.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13(59.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8(36.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1(4.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eP\u0026thinsp;=\u0026thinsp;0.0237*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6(27.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12(54.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 18.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13(59.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8(36.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1(4.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0(0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eP\u0026thinsp;=\u0026thinsp;0.0237*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003eP\u0026thinsp;=\u0026thinsp;0.008*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c9\" namest=\"c6\"\u003e \u003cp\u003eP\u0026thinsp;\u0026lt;\u0026thinsp;0.001*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eSuccess rate:\u003c/h2\u003e \u003cp\u003ePhosphoric acid has shown a 27.3% success rate, while nitric acid has shown a 59.1% success rate, and there was a significant difference between them (P\u0026thinsp;=\u0026thinsp;0.0353). The success rate of nitric acid was 31.8% compared to phosphoric acid (95% CI 2.64\u0026ndash;54.41%), as shown in Fig.\u0026nbsp;4.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eCervical caries present one of dentistry's most challenging and complex restorative problems, affecting the facial and/or the lingual surface of posterior and anterior teeth [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. The etiology of this lesion is complex and multifactorial; the dentist must identify and address the underlying cause prior to initiating the restorative procedure. These factors include long-term accumulation of dental plaque on the teeth, lack of proper oral hygiene, different gingival diseases, hormonal disturbance from pregnancy, exposure to some medications that affect salivary secretion, and finally, the demineralization of enamel due to high consumption of carbohydrates and sweets [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Cervical caries often affect both enamel and dentin, complicating restoration due to the absence of materials that bond effectively to both substrates. The risk of restoration failure increases by approximately 39% when both enamel and dentin are affected, in contrast to lesions confined to enamel. Moreover, many factors determine the success of restoring this condition, such as the amount of sclerotic dentin, which increases with aging, contamination of salivary and gingival fluids, and hypersensitive dentin. Postoperative sensitivity, particularly following acid-etching procedures, is a common complication that can significantly disrupt patients\u0026rsquo; daily activities, reduce overall treatment satisfaction, and potentially compromise pulp vitality over time. Additionally, prolonged or severe sensitivity may contribute to decreased patient satisfaction and, in some cases, could potentially jeopardize pulp vitality over time. Therefore, the longevity of restored cervical cavities is primarily determined by the dentist's skills, methods of cavity preparation, adhesive system, restorative materials used, and the age of the participants [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe adhesive system plays a pivotal role in achieving durable cervical resin composite restorations by establishing intimate contact between the tooth structure and the composite. The primary role of the adhesive is to create an intimate contact between the tooth and the resin composite. Various adhesives have been developed, culminating in the multimode adhesive, applicable in both etch and rinse or self-etch modes. Nevertheless, the optimal bonding strategy that ensures the best clinical outcomes remains undetermined [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Each mode possesses distinct advantages and disadvantages. The etch and rinse mode represents the oldest and most widely employed adhesive technique in dentistry, utilizing phosphoric acid as an etching agent at a concentration of 35\u0026ndash;37%. The application occurs on both enamel (15\u0026ndash;30 seconds) and dentin (10\u0026ndash;15 seconds), leading to demineralization of the enamel surface through the extraction of mineral content, particularly calcium and phosphate, resulting in a microscopically rough surface. The removal of the smear layer and smear plug from the dentin surface generates micropores that facilitate the penetration of the bonding agent, thereby creating a connection between the restoration and the tooth structure. This mode establishes a robust micromechanical bond with enamel and dentin. However, it elevates the risk of postoperative sensitivity, particularly when the dentin becomes etched [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. In response to these limitations, the self-etch mode was introduced. This approach employs a self-etching primer that contains acidic monomers capable of simultaneously etching the enamel and priming the dentin. The induced demineralization was less aggressive than in etch and rinse mode, attributable to the application of a milder acid, which contributed to the preservation of dentin integrity. It decreases the postoperative sensitivity and the bond strength with enamel compared to the etch and rinse mode [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Numerous published articles and systematic reviews indicate that universal adhesives demonstrate superior clinical performance when applied in etch and rinse mode [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA novel concept has been introduced to improve bonding for both enamel and dentin, known as selective dentin etching. This technique involves applying phosphoric acid\u0026mdash;either at a reduced concentration or for a shorter duration\u0026mdash;or using alternative acids that produce favorable effects on the dentin substrate. Such modifications are intended to enhance adhesive-collagen interactions and establish a stable hybrid layer, partly due to the presence of 10-MDP monomer in the universal adhesive, which chemically bonds with calcium ions in hydroxyapatite crystals. This process reduces postoperative sensitivity by minimizing dentinal tubule exposure and fluid movement [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Historically, nitric acid was employed for etching both enamel and dentin in the late 1940s, although it was initially considered too aggressive because it caused excessive demineralization, rendering bonding unpredictable. Nevertheless, nitric acid has recently been reintroduced as an alternative etchant to phosphoric acid [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. The mechanism of action of nitric acid as an etchant is distinct from that of phosphoric acid, as it involves chemical dissolution and surface modification. The application of nitric acid results in demineralization through the dissolution of calcium phosphate crystals in the enamel or dentin, thereby exposing the organic matrix. Additionally, it can interact with calcium ions to form calcium nitrate and hydroxide, which contribute to the sealing of dentinal tubules. The selective demineralization of the enamel surface using nitric acid facilitates the formation of a more porous surface, thereby enhancing the mechanical retention of the adhesive [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe advancements in dental technology have significantly enhanced the significance of tissue engineering. Tissue engineering combines life sciences with engineering principles to develop methods and materials aimed at repairing damaged or diseased tissue via tissue replacement [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. The term \u003cb\u003ebioactive in restorative dentistry\u003c/b\u003e refers to the ability of the material to induce a favorable biological reaction from the surrounding structures, release bioactive ingredients, and compose hydroxyapatite crystals on its surface [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. One of the most widely recognized bioactive materials in dentistry is Bioglass 45S5, named for its composition of Bioglass, which is 45% silicon dioxide (SiO2), 24.5% sodium oxide (Na2O), 24.5% calcium oxide (CaO), and 6% phosphorus pentoxide (P2O5). Silicate-based glasses undergo degradation in body fluids, serving as a reservoir for ions essential for healing. Bioglass serves as an implant device in the human body for the replacement and repair of damaged bones due to its biocompatibility and bioactivity [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Sodium plays a key role in bioactivity by affecting the glass network; the degradation rate and subsequent apatite formation are strongly influenced by the connectivity of the silica network and the phosphate content. Fluoride is essential for constructing acid-resistant fluorapatite crystals rather than hydroxyapatite, and its conjugation with bioactive glass augments the remineralization process [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Using bioactive glass within the dental adhesives aims to enhance the bond strength and the longevity of dental composite restoration. Its high zinc content can protect the collagen matrix from degradation by matrix metalloproteinases (MMPs). Moreover, bioactive glass can reduce micro permeability by remineralizing demineralized areas and enhancing the modulus of elasticity and hardness of the adhesive interface. Additionally, it decreases micro permeability by remineralizing areas deficient in minerals and enhancing both the modulus of elasticity and hardness. This process reduces dentin hypersensitivity by occluding the dentinal tubules by binding them with collagen fibers and precipitating hydroxyapatite. Bioglasses are incorporated into restorative materials as a flowable resin composite to suppress the proliferation of oral bacteria such as Streptococcus mutans and E. coli while maintaining bond strength and enhancing adhesive bioactivity [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. A review of the existing literature reveals a significant gap in clinical trials examining the effects of bioactive adhesives on postoperative sensitivity. A clinical trial conducted in 2002 was the sole relevant study identified, which investigated the bioactive system comprising S-PRG (Surface Pre-reacted Glass Ionomer) and its impact on postoperative sensitivity. This study's findings demonstrate that the bioactive system effectively reduces postoperative sensitivity, which is linked to the release of six key ions: sodium, boron, aluminum, silicon, strontium, and fluoride [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study utilized nitric acid with a mineral-enriched adhesive and a flowable composite liner as the intervention arm. In contrast, the comparator arm used phosphoric acid and universal adhesive in etch and rinse mode with a nanofilled flowable composite frequently used as a restorative system. The manufacturer of a mineral-enriched system asserts that this protocol enhances bonding by attracting ions and protecting and healing substrate. Bioglass facilitates the attraction and exchange of bioactive ions (Ca2+, PO4 3-, F-) with the oral environment and tissue fluids, supported by continuous pH buffering. This mechanism aids in preventing erosion and secondary decay, contributing to the closure of marginal gaps and the preservation of marginal integrity. The current trial results indicate that nitric acid and mineral-enriched systems demonstrated higher postoperative sensitivity than phosphoric acid and standard restorative systems. The results presented in (Tables\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e, and Fig.\u0026nbsp;2,3), can be attributed to the HEMA content of the cleanser, which blocks dentin tubules and decreases the postoperative sensitivity.\u003c/p\u003e \u003cp\u003eFurthermore, the effective bio-regenerative ability of the mineral-enriched system enhances interfacial remineralization and optimizes bonding quality, contributing to the reduction of postoperative sensitivity. Based on these results, the null hypothesis (which stated that there would be no difference between the two systems) was rejected, as a significant difference was found between the intervention and comparator groups. Although there is a paucity of clinical trials evaluating the performance of nitric acid and mineral-enriched systems, previous studies by Francis et al. (2020) and Javed et al. (2024) reported similar postoperative sensitivity outcomes between etch-and-rinse and self-etch modes. This finding contrasts with our results [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. This discrepancy may be due to variations in the comparator groups; our study utilized a nitric acid-based bioactive system rather than a self-etch adhesive. One of the limitations of this study is the lack of an overall clinical assessment of both systems used, which is planned for publication following the completion of the minimum follow-up period according to USPHS guidelines. Furthermore, our research did not encompass a comprehensive assessment of the entire bioactive system in its full complexity. Future research should focus on a comprehensive evaluation of the complete bioactive system to elucidate all components' synergistic effects and overall performance. It is also important to note that this study focused on patients with moderate caries risk; high-risk patients may present unique challenges that exhibit distinct challenges that could affect treatment outcomes, indicating that our findings may not be applicable to that to that population.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eAccording to the framework of this study, the following conclusions are drawn:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eNitric acid and mineral-enriched systems demonstrate significant potential in managing postoperative sensitivity.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eBioactive materials represent an emerging strategy for treating anterior cervical carious lesions, offering enhanced therapeutic outcomes in restorative dentistry.\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\u003eA long-term assessment of the clinical performance of nitric acid and its associated system is recommended.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe combination of a final bioactive restorative material beside the mineral-enriched system used might be of clinical significance.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAdditional clinical trials are needed to assess postoperative sensitivity in diverse clinical scenarios, including variations in lesion depth, sclerosis degree, lesion type, tooth location (with differing functional demands), and other patient-related factors.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003eVAS\u0026nbsp;\u003c/strong\u003eVisual analog scale\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHEMA\u0026nbsp;\u003c/strong\u003eHydroxyethyl Methacrylate\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eE. Coli\u0026nbsp;\u003c/strong\u003eEscherichia coli\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIQR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Interquartile Range\u003c/strong\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank Professor Asmaa Yassin for her scientific support and guidance during this study. Her assistance in the Department of Conservative Dentistry at the Faculty of Dentistry, Cairo University, was invaluable. We appreciate her commitment to our research. Thank you, Professor Yassin, for your support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosure statement:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN.Y, O.H and D.E participated in designing the study. D.E participated in generating the data. O.H did the allocation concealment. \u0026nbsp; N.Y performed all the practical steps and acting as main researcher and corresponding author. D.E assessed the outcome of the study. N.Y wrote the manuscript. O.H and D.E revised the final version of the manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis article was fully funded by the researchers.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Research Ethical Committee at Faculty of Dentistry, Cairo University with number \u003cstrong\u003e11/7/23. \u003c/strong\u003eThis randomized clinical trial study was conducted at the Faculty of Dentistry - Cairo University following the ethical principles of the World Medical Association Declaration of Helsinki. All patients were informed of the goals and procedures of the trial before consenting to participate and signing the informed consent form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNourane Yasser Ali (N.Y) (corresponding author):\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePhD candidate, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt and Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Egyptian Russian University, Egypt. \u003cstrong\u003eEmail:\u003c/strong\u003e [email protected]\u003c/p\u003e\n\u003cp\u003eORCID: (0009-0002-7240-1324)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDina Ezz (D.E):\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLecturer of Conservative Dentistry, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. \u003cstrong\u003eEmail:\u003c/strong\u003e [email protected]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eORCID:(0000-0002-7178-1065)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOlfat El Sayed Hassanein (O.H):\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProfessor of Conservative Dentistry, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. \u003cstrong\u003eEmail:\u003c/strong\u003e [email protected]\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;ORCID: (0009-0006-6269-5866)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKolus T, Ucar AY. A systematic review and meta-analysis of the success of resin composite restorations. J Adv Oral Res. 2022;13:157\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e2, Munchow EA, Bottino MC. Dental adhesives: from earlier products to bioactive and smart materials. In: Mittal KL, Etziler FM, editors. Adhesion in pharmaceutical biomedical and dental fields.1st edition. Wiley-Scrivener;2017. pp. 331\u0026ndash;368.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNicholson J, Czarnecka B. Composite resins. In: Laura Overend, editor. Materials for the Direct Restoration of Teeth. 1st edition. Cambridge: Matthew Deans;2016. pp. 37\u0026ndash;67.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDermarco FF, Collares K, Correa MB, Cenci MS, Moraes RR, Opdam NJ. Should my composite restorations last forever? Why are they failing? Dent Mater J. 2017;31:92\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlbelasy EH, Hamama HH, Chew HP, Montaser M, Mahmoud SH. Secondary caries and marginal adaptation of ion releasing versus resin composite restorations: a systematic review and meta-analysis of randomized clinical trials. Sci Rep. 2022;12:1\u0026ndash;17.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeintze SD, Ruffieux C, Rousson V. Clinical performance of cervical restorations\u0026mdash;A meta-analysis. Dent Mater. 2010;26(10):993\u0026ndash;1000.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePerdigao J, Ceballos L, Giraldez I, Baracco B, Fuentes M. Effect of a hydrophobic bonding resin on the 36-month performance of a universal adhesive- a randomized clinical trial. Clin Oral Investig. 2020;24:765\u0026ndash;76.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStape THS, Wik P, Mutulay MM, Al ani AAS, Mutulay AT. Selective dentin etching: a potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018;86:14\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRisnes S, Li C. On the method of revealing enamel structure by acid etching. Aspects of optimization and interpretation. Microsc Res Tech. 2019;82:1668\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLadion LG, Bernal A, Calderon D, Cortes D. Bioactive materials in restorative dentistry: a literature review. SVOA Dent. 2021;4:74\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFerracane JL, Sidhu SK, Melo BDS, Yeo MAS, Diogenes ISL, Darvell A. BW. Bioactive dental materials: Developing, promising, confusing. JADA.2023; 2: 1\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Ouml;zcan M, Garcia LDFR, Volpato CAM. Bioactive materials for direct and indirect restorations: concepts and applications. Front Dent Med. 2021;2:1\u0026ndash;10.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCoral C, Grez PV, Letelier M, Campos EA, Dourado AL, Fenandez E. Effect of oxalic acid\u0026ndash;based desensitizing agent on cervical restorations on hypersensitive teeth: a triple-blind randomized controlled clinical trial. J Oral Facial Pain Headache. 2016;30:330\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl morsy K, Abdalla AI, Shalaby ME. Clinical evaluation of three adhesive systems in class V carious lesions. Tanta dent j 2018, 15:132\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020;24:1569\u0026ndash;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZanatta RF, Silva TM, Esper M, Bersciani E, Goncaves S, Caneppele T. Bonding performance of simplified adhesive systems in non-carious lesions at 2 years follow up: a double blind randomized clinical trial. J Oper Dent. 2019;44:476\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOz FD, Kutuk ZB, Ozturk C, Soleimani R, Gurgan S. An 18-month clinical evaluation of three different universal adhesives with a universal flowable composite resin in the restoration of non-carious cervical lesions. Clin Oral Investig. 2019;23:1443\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHall C, Mason S, Cooke J. Exploratory randomized controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017;60:36\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOtakhoigbogie U, Osagbemiro BB, Egwim IC. A comparison of three pain assessment scales in the assessment of pain among dental patients in Port Harcourt. Eur J Med Health Sci. 2020;2(4):1\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaghaireh GA, Albashaireh ZS, Allouz HA. Postoperative sensitivity in posterior restorations restored with self-adhesive and conventional bulk-fill resin composites: A randomized clinical split-mouth trial. J Dent. 2023;137:1\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZabeu GS, Mosquim V, Bastos NA, Sntin DC, Agulhari MAS, Wang L. Dental cervical lesions: how the etiologies imply in different approaches for long lasting performance. Arch Health Investig. 2022;11(1):125\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStewardson D, Thornley P, Bigg T, Bromage C, Browne A, Cottam D, Dalby D, Gilmour J, Horton J, Roberts E, Westoby L, Dietrich T, Burke T. The survival of Class V restorations in general dental practice. Br Dent J. 2012;212:1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKubo S. Longevity of resin composite restorations. J Dent Sci. 2011;47:43\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHong X, Huang Z, Tong Z, Jiang H, Su M. Clinical effects of different etching modes for universal adhesives: a systematic review and meta-analysis. Ann Palliat Med. 2021;10(5):5462\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePashley DH, Tay FR, Breschi L, Tj\u0026auml;derhane L, Carvalho RM, Carrilho M, Mutluay AT. State of the art etch-and-rinse adhesives. Dent Mater J. 2011;27(1):1\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYousaf A, Aman N, Manzoor MA, Shah JA, Dilrasheed. Postoperative sensitivity of self etch versus total etch adhesive. J Coll Physicians Surg Pak. 2014;24(6):383\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStape THS, Wik P, Mutluay MM, Al-Ani AAS, Mutluay AT. Selective dentin etching: a potential method to improve bonding effectiveness of universal adhesives. J Mech Behav Biomed Mater. 2018:1\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBlosser RL. Time dependence of 2.5% nitric acid solution as an etchant on human dentin and enamel. Dent Mater J. 1990;6:83\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRisnes S, Li C. On the method of revealing enamel structure by acid etching. Aspects of optimization and interpretation. Microsc Res Tech. 2019;82:1668\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZafar MS, Khurshid Z, Almas K. Oral tissue engineering progress and challenges. J Tissue Eng Regen Med. 2015;12(6):387\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBaino F, Hamzehlou S, Kargozar S. Bioactive glasses: where are we and where are we going? J Funct Biomater. 2018;9:1\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSkallevold HE, Rokaya D, Khurshid Z, Zafar MS. Bioactive glass application in dentistry. Int J Mol Sci. 2019;20:1\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMai S, Zhang Q, Liao M, Ma X, Zhong Y. Recent advances in direct adhesive restoration resin based dental materials with remineralizing agents. Front Dent Med. 2022;3:1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAli S, Farooq I, Iqbal K. A review of the effect of various ions on the properties and the clinical applications of novel bioactive glasses in medicine and dentistry. Saudi Dent J. 2014;26:1\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGordan VV, Mj\u0026ouml;r IA. Short- and long-term clinical evaluation of post-operative sensitivity of a new resin-based restorative material and self-etching primer. Oper Dent. 2002;27(6):543\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFrancis T, Sakkir N, Soe HHK, Yeow TY, Hwe HZ, Tze ALM. Postoperative sensitivity of selective-etch and total-etch techniques in composite resin restorations: an in vivo study. JCDR. 2020;14(4):1\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJaved K, Noor N, Nasir MZ, Manzoor MA. Comparison of postoperative hypersensitivity between total-etch and universal adhesive system: a randomized clinical trial. Sci Rep. 2024;14:1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\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":"Acid etch, Adhesive, Clean \u0026 Boost, Cleanser, Flowable, Mineral-enriched, Nitric acid, Postoperative sensitivity, RE-GEN","lastPublishedDoi":"10.21203/rs.3.rs-6088218/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6088218/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/em\u003e Phosphoric acid is considered the most commonly used acid for the pretreatment of tooth structures prior to resin composite restoration. However, its use on dentin substrates is frequently associated with postoperative sensitivity. Therefore, this study aimed to evaluate the clinical performance of a multifunctional protocol comprising a nitric acid etch, mineral-enriched adhesive, and flowable composite liner compared with a conventional protocol using phosphoric acid, a universal adhesive, and a regular flowable composite liner in cervical carious anterior cavities.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/em\u003e A total of 26 individuals presenting with 44 cervical anterior carious lesions were recruited and randomized into two equal groups. One group received treatment with a nitric acid etch \u003cstrong\u003e(Clean and Boost dentin enamel cleanser, Vista Apex, USA)\u003c/strong\u003e in conjunction with a mineral-enriched adhesive and a flowable composite liner \u003cstrong\u003e(RE-GEN, Vista Apex, USA).\u003c/strong\u003e The other group received treatment with phosphoric acid (Scotchbond Universal Etchant, 3M ESPE), a universal adhesive \u003cstrong\u003e(Single Bond Universal Adhesive, 3M ESPE)\u003c/strong\u003e, and a regular flowable composite liner \u003cstrong\u003e(Filtek Supreme, 3M ESPE)\u003c/strong\u003e. Both groups received a final restoration using a packable nanohybrid resin composite \u003cstrong\u003e(Filtek Z350XT, 3M ESPE)\u003c/strong\u003e. Postoperative sensitivity was evaluated using a visual analog scale at baseline, 6, and 12 months. The data was statistically analyzed using the Chi-Squared test with a statistical significance level set at (P ≤ 0.05). Intragroup comparisons for each intervention were performed using Cochran's Q test, with a statistical significance level set at (P ≤ 0.0083) after Bonferroni correction. Success rates were compared using the Z test for independent proportions, and relative risk was calculated to assess clinical significance. All tests were two-tailed, with a confidence level of 95% and a study power of 80%.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/em\u003e After 12 months, the risk of postoperative sensitivity was 44% lower in the nitric acid group compared to the phosphoric acid group (RR= 0.5625, 95%CI (0.3201 to 0.9884); P = 0.0454). The success rate for the phosphoric acid protocol was 27.3%, whereas the nitric acid protocol achieved a success rate of 59.1%, with a statistically significant difference (P = 0.0353).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/em\u003e The use of nitric acid combined with mineral-enriched adhesive and a flowable composite liner system is a promising approach to reducing postoperative sensitivity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e This study was registered at \u003cstrong\u003ewww.clinicaltrials.gov\u003c/strong\u003e under the identification number \u003cstrong\u003eNCT05928533\u003c/strong\u003e on \u003cstrong\u003e26/06/2023.\u003c/strong\u003e\u003c/p\u003e","manuscriptTitle":"Performance of Nitric acid and Mineral Enriched System Versus Phosphoric Acid and Universal Adhesive in cervical carious lesions: a randomized clinical trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-04 07:06:40","doi":"10.21203/rs.3.rs-6088218/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":"29a98db0-d327-4ba4-9a1a-f84225a0e548","owner":[],"postedDate":"April 4th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-23T17:23:09+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-04 07:06:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6088218","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6088218","identity":"rs-6088218","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}