Calcium Silicate Liner versus No Liner in Selective Caries Removal: A One-year Randomized Clinical Trial

Calcium Silicate Liner versus No Liner in Selective Caries Removal: A One-year 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 Calcium Silicate Liner versus No Liner in Selective Caries Removal: A One-year Randomized Clinical Trial Patricia Terceño, Juan Gonzalo Olivieri, MªVictoria Fuentes, Laura Ceballos This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7786121/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 26 Feb, 2026 Read the published version in BMC Oral Health → Version 1 posted 12 You are reading this latest preprint version Abstract Background/Objectives: Selective removal to soft dentine (SRSD) is recommended to minimize pulp exposure in deep carious lesions. The use of calcium silicate-based liners has been advocated to en-hance pulp protection; however, their true clinical benefit remains controversial. This study aimed to compare the clinical and radiographic success of the SRSD technique with and without the use of a bioactive liner in permanent posterior teeth with closed apex after 12 months. Methods: A double-blind, randomized controlled trial was conducted in patients aged 15–62 years with deep carious lesions in posterior permanent teeth with normal or reversible pulpitis. Teeth were randomly assigned to two groups: application of a hydraulic calcium silicate-based cement (Biodentine™) or no liner (direct adhesive procedure). All restorations were performed under rubber dam isolation. The primary outcome was treatment success (maintained or lost vitality at 12 months), with the tooth as the unit of analysis. Success was defined as absence of symptoms, normal pulp sensibility response, no clinical signs of inflammation or infection and absence of periapical pathology on radiographs. Continuous and categorical variables were compared using Wilcoxon and Fisher’s exact tests, respectively, with FDR-adjusted p-values (α = 0.05). Results: A total of 45 teeth in 32 patients were treated, with 33 teeth available for 12-month fol-low-up. Both groups achieved 100% success rates with no statistically significant differ-ences. All teeth maintained normal pulp responses, were asymptomatic, and showed healthy periapical structures. Restoration quality was acceptable according to FDI criteria, with no failures or adverse events recorded. Conclusions: After 12 months, the use of a calcium silicate-based liner did not significantly impact the clinical or radiographic success of the SRSD technique in deep caries lesions. A direct adhesive approach without a liner may be a reliable, simpler, and cost-effective alter-native for maintaining pulp vitality. Trial registration: The study was approved by the University Ethics Committee (protocol code 0212202023220) and registered at ClinicalTrials.gov (Identifier: NCT04743219; date of registration: February 5, 2021). Selective Caries Removal Calcium Silicate Cements Dental Caries Dental Pulp Clinical trial Treatment Outcome Figures Figure 1 Figure 2 1.Background Thanks to better understanding of the physiology of the dentin–pulp complex and its re-sponse capacity, modern conservative dentistry prioritizes preserving pulpal health to maintain its developmental and defensive properties [ 1 ]. This principle is critical when treating deep carious lesions, defined as those reaching the inner quarter of dentin and presenting a risk of pulp exposure during operative treatment, although radiographically a zone of sound dentin between caries and pulp can still be detected1. To manage these deep lesions, two treatments are currently accepted according to the International Caries Consensus Collaboration (ICCC): stepwise removal (SW) or selective removal to soft dentin (SRSD) [ 2 ]. These techniques aim to minimize pulp exposure and allow the dentin–pulp complex to activate its defense mechanisms [ 3 ]. The SW technique was the one originally described to deal with deep carious lesions and shares with SRSD an incomplete removal of caries tissue to promote tertiary dentin formation. The difference is that SW involves a two-stage procedure. The cavity is sealed with a temporary filling and reopened, between 6 and 12 months later, to perform the removal of the remaining demineralized dentin and place a definitive restoration [ 1 ]. However, recent evidence questions the need for a second stage, highlighting that re-entry may be unnecessary, reducing costs, discomfort, and the risk of patients not returning [ 4 ]. Hence, the single-visit SRSD approach is now widely recommended [ 5 ]. SRSD consists of leaving a layer of soft carious tissue over the floor on the pulpal aspect of the cavity while removing peripheral caries to hard dentin consistency, to ensure an adequate bonding substrate to achieve a hermetic seal with the restoration [ 6 ]. Consequently, nutrient supply to bacteria is interrupted, the pH lesion modified, the toxins reduced and tertiary dentin formation and dentinal tubule sclerosis are promoted, favouring remineralization [ 7 , 8 ]. Without the obligation to eradicate the entire bacterial population, the need for removal of larger amounts of tissue is reduced and so it is the risk of pulp exposure [ 9 ]. The clinical success rates reported for SRSD in deep lesions are high, ranging between 84% and 100% with predictable long-term results [ 10 – 12 ]. The use of a biologically based material for indirect pulp capping has been recommended for therapeutic reasons as the dentin thickness over the pulp cannot be accurately assessed clinically [ 13 – 15 ]. According to the position statement of the European Society of Endodontology (ESE), a hydraulic calcium silicate would be the material of choice, with the possibility of using also a conventional glass–ionomer cement [ 14 ]. Hydraulic calcium silicate cements offer several advantages: they are highly biocompatible, reduce the risk of adverse tissue reactions provide antimicrobial properties due to their high alkalinity, and also offer excellent marginal sealing due to slight expansion upon setting, minimizing the risk of microleakage [ 16 , 17 ]. Additionally, they release beneficial ions such as calcium and silicate, supporting tissue mineralization [ 18 ]. Their dimensional stability, mechanical strength, and radiopacity further contribute to their effectiveness and clinical reliability [ 17 ]. Among them, Biodentine™ (Septodont, St. Maur-des-Fossés, France) was developed as a calcium silicate-based material offering easier handling, shorter setting time, lower risk of tooth discoloration, and improved cost-effectiveness [ 19 ]. It is one of the most studied calcium silicate-based cements (also known as “smart dentin replacement”), composed of tricalcium silicate, calcium carbonate, and zirconium oxide in its powder phase, with a water-based liquid containing calcium chloride as setting accelerator and water-reducing agent [ 20 ]. Despite its excellent properties, Biodentine™, as well as calcium silicate cements in general, present other issues that have limited their adoption in clinical practice. These include high cost, difficulty of application, lack of intrinsic adhesion to dentin and to the restorative material, long setting time and the potential risk of tooth discoloration [ 21 ]. Given these drawbacks, robust clinical evidence is essential to justify their use and to confirm that they offer a tangible benefit in improving treatment outcomes. Clinical, radiographic, and microbiological evaluations have demonstrated that achieving a hermetic seal alone can inactivate active deep carious lesions [ 22 ]. Moreover, self-etch adhesives also stimulate early pulp repair after selective removal of carious tissue [ 22 ]. Therefore, a good marginal seal may be sufficient to control caries progression, without necessarily attributing a major role to the lining material [ 23 ]. Most clinical studies evaluating SRSD technique have used different liner materials such as glass ionomer cement, calcium hydroxide, Biodentine™ or MTA [ 10 , 24 ]. However, very few have explored this technique without any liner material [ 12 , 25 ]. Therefore, more clinical trials are needed to investigate whether the use of a calcium silicate-based material is truly essential to enhance the success rate of the SRSD technique [ 26 ]. Accordingly, the aim of the present study was to compare the clinical and radiographic success of SRSD using a calcium silicate-based liner versus a direct adhesive procedure in permanent posterior teeth restored with resin composite after 1 year. The null hypothesis for this study was that there is no difference in success rate when comparing SRSD with and without a calcium silicate-based liner in permanent posterior teeth with deep carious lesions. 2. Materials and Methods 2.1. Study Design This was a prospective, parallel group, randomized controlled clinical trial with a 1:1 allocation ratio. The study was approved by the University Ethics Committee (protocol code 0212202023220) and registered at ClinicalTrials.gov (Identifier: NCT04743219). This study was conducted in accordance with the CONSORT (Consolidated Standards of Re-porting Trials) guidelines [27]. Written informed consent was obtained from all participants prior to inclusion, and from the parents or legal guardians of participants under the age of 16. Recruitment and follow-up took place at the University Dental Clinic between February 2021 and May 2024. 2.2. Participants Patients aged over 14 years who attended the University Dental Clinic were consecutively screened for eligibility. The following variables were recorded: sociodemographic data, tooth type (premolar or molar; maxillary or mandibular), caries lesion extension, pulpal diagnosis and caries risk. Caries risk was determined using the Cariogram software (Malmö University, Sweden), categorizing patients into high (0–20%), moderate (21–80%), or low (>80%) probability of avoiding new cavities. Inclusion Criteria: Permanent posterior teeth with deep carious lesions radiographically extending at least two-thirds into dentin. A radiographically visible band of sound dentin separating the carious lesion from the pulp chamber roof. Positive response to cold testing (–50 °C Roeko Endo-Frost, Coltène, Germany) indicating normal pulp or mild reversible pulpitis (sensibility or pain lasting up to 15 - 20 seconds and settling spontaneously) [28]. Teeth had to be restorable with a direct restoration. Exclusion criteria: Teeth with spontaneous pain, prolonged response for more than 20 seconds to cold testing, persistent dull throbbing pain and tenderness to percussion or pain exacerbated [28]. Patients with persistent periodontal disease, pregnant or lactating, with systemic illness, immunosuppression, or allergy to study materials. 2.3. Sample Size The sample size was determined by convenience based on the number of eligible patients during the recruitment period. 2.4. Randomization and Allocation Concealment Randomization was performed using a computer-generated random sequence (www.randomizer.org) with equal allocation to two experimental groups. Allocation was managed by the principal investigator, who was the only individual aware of the sequence. Due to the nature of the intervention, the operator could not be blinded, but both patients and outcome examiners were blinded to group assignment. A single operator performed patient screening, including clinical and radiographic examinations. Standardized bitewing and periapical preoperative radiographs were obtained using the same digital imaging system (RVG 6200, Carestream Health, USA). 2.5. Interventions All procedures were performed under local anesthesia and rubber dam isolation by a single experienced operator (8 years of clinical practice). Carious dentin was removed with low-speed tungsten carbide burs (H1, Komet Dental, Lemgo, Germany) and manual excavators until hard dentin was reached peripherally, preserving a layer of soft dentin on the pulpal floor to avoid pulp exposure. According to randomization, the teeth were allocated to the following groups after se-lective caries removal to soft dentin (SRSD): CS Group (Calcium Silicate Liner): Biodentine™ (Septodont) was mixed for 30 seconds, following manufacturer’s instructions and placed in a 2 mm layer over the pulpal floor. After a 12-minute setting time, selective enamel etching was performed with 3M™ Scotchbond™ Universal Etchant (Solventum, Maplewood, Minnesota, USA) for 30 sec-onds. 3M™ Scotchbond™ Universal Plus adhesive (Solventum) was actively applied for 20 seconds, air-thinned, and light-cured for 20 seconds (SmartLite Pro, Dentsply Sirona Charlotte, North Carolina, U.S.; 1250 mW/cm²). The cavity was restored incrementally with Ceram.X Universal composite (Dentsply Sirona) and each 2 mm layer was light-cured for 20 seconds. NL Group (No Liner): No liner was placed. An identical adhesive protocol as the described above for CS group was carried out directly on dentin and enamel, followed by restoration with Ceram.X Universal composite using the same technique. 2.6. Outcomes The primary outcomes were clinical and radiographic treatment success. Clinical success was defined as: absence of symptoms (no spontaneous pain or lingering sensitivity), positive response to pulp sensibility tests within normal limits, no clinical signs of inflammation or infection (e.g., swelling, sinus tract, abscess) [14]. Radiographic success required no evidence of apical periodontitis or periodontal ligament space widening and no pathological internal or external root resorption [14]. Secondary outcome included direct resin composite restoration performance according to the FDI criteria (esthetic, functional, and biological properties) [29]. For statistical analysis, categories 1 and 2 were grouped as “clinically acceptable,” whereas scores ≥3 were considered “clinically unacceptable.” Restorations rated as “clinically unsatisfactory” or “poor” in any category were considered failures. 2.7. Follow-Up Patients were evaluated clinically at 1 and 6 months by the operator and 12 months postoperatively by two blinded, calibrated examiners. Standardized bitewing and per-iapical radiographs were taken immediately after treatment and at 6- and 12-month recalls using film holders and the XCP-DS positioner system (Carestream Health). Ra-diographs were withheld from the examiners until completion of the clinical assessments to ensure blinding. 2.8. Statistical Analysis Statistical analysis was performed using the openxlsx3 v.4.2.5 package in the R envi-ronment. The primary outcome was success/failure of each treated tooth (binary variable: maintained or lost vitality at 1 year). The tooth was considered the primary unit of analysis. Continuous variables (age) were expressed as mean and standard deviation (SD) or median and interquartile range (IQR), while categorical variables (gender, tooth type, cavity type, probability of avoiding new cavities and pulpal diagnosis,) were expressed as absolute and relative frequencies. Comparisons between groups were performed using the Wilcoxon test for continuous variables and Fisher’s exact test for categorical variables. All p-values were adjusted using the false discovery rate (FDR) method to account for multiple comparisons, with a significance level set at α = 0.05. 3. Results 3.1 Participant Flow and Baseline Characteristics A total of 45 teeth from 32 patients, with ages between 15 and 62 years, met the inclusion criteria and were randomized. Details of patient flow, allocation, and follow-up are illustrated in Figure 1. At the 12-month recall, the CS group showed 4 lost restorations (17.4%) compared with 8 (36.4%) in the NL group. Similarly, 3 patients (15.8%) were lost in the CS group versus 5 (38.5%) in the NL group. Although the proportion of losses was almost twice as high in the NL group, Fisher’s exact test revealed no statistically significant differences between groups for restorations (p = 0.189) or patients (p = 0.219). 3.2 Descriptive Analysis of Treated Teeth The mean age of participants in the CS group was 25.74 years (SD = 10.7), while the NL group presented a mean age of 22.86 years (SD = 5.5). The difference between groups was not statistically significant (p = 0.592). The distribution of gender did not differ significantly between groups, with 78.3% females in the CS group versus 63.6% in the NL group (p = 0.337). Similarly, the probability of avoiding new caries was 23.9% in the NL group versus 19.2% in the CS group; the difference was not statistically significant (p = 0.439). Table 1 presents the baseline characteristics of the treated teeth according to the assigned treatment. Table 1. Description of baseline characteristics by treatment group. Variable CS, n (%) NL, n (%) p-value Tooth Type 0.437 Maxil. premolars 12 (52.2%) 7 (31.8%) Maxil. molars 3 (13%) 2 (9.1%) Mand. premolars 1 (4.4%) 2 (9.1%) Mand. molars 7 (30.4%) 11 (50%) Cavity Type 0.113 Occlusal 6 (26.1%) 5 (22.7%) Occluso-mesial 4 (17.4%) 5 (22.7%) Occluso-distal 13 (56.5%) 12 (54.6%) Pulp Diagnosis 0.357 Normal 9 (39.1%) 15 (68.2%) Reversible pulpitis 14 (60.9%) 7 (31.8%) Legend: CS = calcium silicate liner; NL = no liner. There were no statistically significant between the test and the control groups regarding tooth, cavity defect and preoperative pulp diagnosis (p>0.05). The analysis of cohort homogeneity did not find significant differences depending on the material used. Moreover, most teeth (95.6%) exhibited physiological probing depths, nearly 98% had an opposing antagonist tooth, and 93% had adjacent teeth present. A balanced distribution across groups was present. 3.3 Success Rate Both groups demonstrated a 100% success rate after 12 months, as all evaluated teeth exhibited a normal pulp response to cold testing, a negative percussion response, patients were asymptomatic, radiographically normal periapical structures were seen and 97% had physiologic probing depth. Therefore, no significant difference was observed between the group treated with Biodentine TM and the group without a liner. No failures or adverse events were recorded. At the 12-month follow-up, according to the FDI World Dental Federation criteria [29], both groups demonstrated high clinical performance, with most of the restorations rated as clinically excellent or good. Comprehensive details regarding the evaluation of the restorations are provided in Table 2. No statistically significant differences were found between CS and NL groups in surface luster, colour match and translucency, marginal staining, or other esthetic, biological, and functional parameters (p > 0.05). The only exception was anatomical form, in which the NL group scored 100% acceptable compared with 89% in the CS group, a difference that reached statistical significance (p = 0.001). Overall, the clinical performance of restorations was comparable between the two groups after 12 months of follow-up. Table 2. Restoration evaluation by assigned treatment. GROUP CS GROUP NL 1 2 3 4 5 1 2 3 4 5 Aesthetic properties Surface luster 26% 68% 5% 0 0 36% 50% 7% 7% 0 Surface staining 95% 5% 0 0 0 86% 14% 0 0 0 Marginal staining 89% 11% 0 0 0 93% 7% 0 0 0 Colour match and translucency 42% 47% 11% 0 0 50% 36% 14% 0 0 Functional properties Anatomical form 47% 42% 11% 0 0 29% 71% 0 0 0 Fracture and retention 79% 16% 5% 0 0 86% 14% 0 0 0 Marginal adaptation 58% 37% 5% 0 0 57% 43% 0 0 0 Occlusal contour and wear qualitatively 100% 0 0 0 0 100% 0 0 0 0 Occlusal contour and wear quantitatively 100% 0 0 0 0 100% 0 0 0 0 Approximal anatomical form contact point 78% 0 6% 0 0 46% 0 15% 0 0 Approximal anatomical form contour 50% 33% 0 0 0 46% 8% 8% 0 0 Radiographic examination (when applicable) 95% 5% 0 0 0 100% 0 0 0 0 Patient’s view 100% 0 0 0 0 100% 0 0 0 0 Biological properties Postoperative (hyper-) sensitivity and tooth vitality 100% 0 0 0 0 100% 0 0 0 0 Recurrence of caries, erosion, abfraction 100% 0 0 0 0 100% 0 0 0 0 Tooth integrity 100% 0 0 0 0 100% 0 0 0 0 Periodontal response (always compared to reference tooth) 100% 0 0 0 0 93% 7% 0 0 0 Adjacent mucosa 100% 0 0 0 0 100% 0 0 0 0 Oral and general health 100% 0 0 0 0 100% 0 0 0 0 Legend: Evaluated according to the FDI World Dental Federation criteria using a 5-point scale: 1 = clinically excellent, 2 = clinically good, 3 = clinically sufficient/satisfactory, 4 = clinically unsatisfactory, 5 = clinically poor (percentages). CS = calcium silicate liner; NL = no liner. 4. Discussion The results of this randomized controlled clinical trial showed that SRSD in deep carious lesions with normal or reversible pulpitis achieved a 100% clinical and radiographic success rate at 12-month follow-up, regardless of whether a calcium silicate-based liner was used. Therefore, the null hypothesis must be accepted. SRSD is considered and effective approach for managing deep carious lesions in vital permanent teeth without signs of irreversible pulpitis [ 3 ]. In agreement, our results have demonstrated that SRSD can successfully maintain pulpal health even when soft, de-mineralized dentin was intentionally retained, reinforcing the biological foundation and clinical value of minimally invasive approaches in managing deep carious lesions. This study is consistent with a recent study by Gözetici et al. which reported 100% success with the SRSD technique [ 12 ]. Similarly, long-term clinical trials by Maltz et al. have demonstrated success rates of 90–91% over 3–10 years, supporting the reliability of SRSD in maintaining pulp vitality [ 11 , 30 ]. Moreover, SRSD has been associated with a significantly lower risk of pulp exposure compared to non-selective excavation [ 3 , 31 ] for which reason it has been considered the preferred treatment option when carious lesions extend beyond two-thirds of the dentin [ 32 ]. In line with this, no cases of pulp exposure were observed in our study, further supporting this assertion. Our analysis also revealed that gender and tooth type had no influence on treatment outcomes, consistent with previous studies [ 25 , 33 ]. Patient age was also not relevant; our youngest patient was 15 and the oldest 62, with no significant differences between them, corroborating earlier reports [ 6 , 12 , 34 ]. One of the most debated aspects of the SRSD is the selection of a liner material. Bio-dentine™ strengthens pulpal defense, promotes dentin remineralization, ensures long-term biocompatibility without compromising aesthetics and stimulates odontoblastic activity [ 35 – 38 ]. Its excellent clinical performance has been demonstrated in multiple longitudinal studies, with success rates of approximately 96–100% at 12 months and values close to 92% at three-year follow-up [ 39 ]. However, whether the use of a calcium silicate–based liner is essential for improving the success rate of SRSD has not been proved. In the present randomized controlled trial, the use or omission of a calcium silicate–based liner, specifically Biodentine™, did not significantly influence the clinical or radiographic success of the SRSD technique after 12 months. These findings are consistent with previous studies reporting that the absence of a liner did not increase the risk of pulpal complications in deep occlusal cavities [ 4 , 25 , 40 ]. Similarly, Gözetici et al also observed no detrimental impact on success rates when a liner was not applied [ 12 ]. Corralo et al., 2013 further confirmed that clinical success (no clinical symptoms or radiographic signs of pulpitis or necrosis) could be achieved without a cavity liner, demonstrating comparable outcomes when different liners were tested against inert wax following partial caries removal in permanent teeth with deep lesions [ 41 ]. Importantly, regardless of the liner used, adequate sealing proved crucial, as it was consistently associated with dentin hardening, reduced bacterial contamination, and dentin reorganization [ 41 ]. The thickness of remaining dentin seems to influence the most in the nature and extent of dentin repair, as a sufficient dentin barrier protects the pulp from irritants and allows odontoblasts to reactivate their healing potential and deposit reactionary tertiary dentin once bacterial load is reduced and an adequate seal is established [ 42 , 43 ]. In our study, particular care was taken during case selection to ensure that an appropriate dentin thickness was preserved, which may account for the favorable outcomes obtained. This highlights that the clinical success of SRSD depends less on the choice of liner material than on maintaining sufficient dentin to protect pulpal vitality, further supporting the notion that sealing quality and residual dentin thickness are the true determinants of long-term success. Within this context, the routine use of materials like Biodentine™ should be justified by clear clinical benefits. To date, such benefits have not been conclusively demonstrated, especially considering its higher cost, longer setting time, and lack of adhesion to both tooth structure and composite resin; factors that complicate its placement, particularly in narrow upper premolar cavities, as previously reported by Gözetici et al [ 12 ]. The success of vital pulp treatments has been closely associated with the meticulous ex-ecution of the restorative procedure, as achieving an optimal marginal seal in the same clinical session is essential. To ensure this, all interventions were performed under ab-solute isolation with a rubber dam, as recommended by ESE [ 14 ]. This approach mini-mizes bacterial contamination, enhances adhesive performance, reduces postoperative sensitivity, and contributes to a more predictable and durable marginal seal [ 44 ]. However, while most studies employed rubber dam isolation during procedures [ 10 , 25 , 41 ]; favorable outcomes have also been reported without it. Banomyong et al. observed no pulpal complications after 2 years, Koc Vural et al. who reported 82.9% retention at 5 years, and Gözetici et al. who achieved 100% success [ 40 , 45 , 12 ]. The adhesive procedure, which is key to achieving a stable long-term marginal seal, was performed using a universal adhesive system. This type of adhesives has been shown to perform very well in clinical settings, with several studies reporting high success rates and restoration durability over a 5-year period [ 46 – 48 ]. The presence of enamel is con-sidered fundamental for the long-term success of adhesive restorations. Enamel provides a highly mineralized and stable substrate that enables durable micromechanical retention and stronger bonding compared to dentin [ 49 ]. For this reason, particular emphasis was placed on preserving enamel whenever possible during cavity preparation. The adhesive was applied using a selective enamel etching technique, which combines phosphoric acid application on enamel with self-etching on dentin. This approach has been associated with improved marginal adaptation and reduced discoloration, thereby enhancing the longevity and stability of the adhesive interface [ 50 ]. With respect to restoration outcomes, all restorations remained functional and symp-tom-free and were clinically acceptable according to FDI criteria with no significant dif-ferences between the CS and NL groups [ 29 ]. This should be interpreted with caution given the relatively short observation period of 12 months, which may be insufficient to detect changes in composite restorations over time. Additionally, cavity type did not influence the clinical or radiographic success of the treatment, in agreement with Maltz et al. and Gözetici et al. [ 31 , 12 ]. The longevity of restorations is not only determined by the restorative material and operative technique, but also by patient- and tooth-related factors. Larger restorations are more prone to failure due to higher stress distribution and reduced residual tooth structure, which can compromise marginal integrity and lead to secondary complications [ 51 , 52 ]. In addition, patients with a high caries risk present a greater likelihood of developing recurrent lesions adjacent to restorations, which negatively impacts their long-term survival [ 53 ]. In the present study, participants will continue to be monitored, as the 12-month follow-up represents only a short-term evaluation. Longer observation periods are needed to provide more robust evidence regarding the influence of restoration size and caries risk on clinical outcomes. Few clinical trials have evaluated the long-term outcomes of restorations after SRSD is performed in permanent teeth. The available studies consistently support its success, demonstrating favorable outcomes over time [ 3 , 54 ]. In addition, our findings are in agreement with previous evidence showing that the type of liner placed beneath the restoration does not play a decisive role in treatment success, as sealing ability rather than liner selection appears to be the critical factor for long-term survival [ 25 , 41 , 55 ]. Despite these promising results, several limitations must be acknowledged. First, the relatively small sample size and the limited observation period of 12 months restrict the strength of the conclusions. Second, the high dropout rate observed during follow-up reflects the inherent challenges of prospective dental research; in our study, a possible explanation is that patients perceived the procedure as routine and underestimated the importance of attending follow-up appointments. Finally, the fact that the study was conducted under highly controlled university conditions may limit the generalizability of the findings. At the same time, the study also presents important strengths, including strict ran-domization, clearly defined inclusion criteria, and standardized treatment delivered by a single operator, which enhance the internal validity of the results. Furthermore, clinical trials provide valuable insights that laboratory investigations—constrained by their lack of biological and behavioural variability—cannot fully capture. Future research with larger sample sizes, longer follow-up periods, and evaluations in broader clinical settings is required to validate these findings and further consolidate the evidence base for SRSD. 5. Conclusions At 12 months, selective removal of carious tissue to soft dentin (SRSD) in deep lesions with normal or reversible pulpitis demonstrated clinical and radiographic success rates identical between teeth treated with a calcium silicate–based liner and those restored directly with an adhesive procedure, indicating that both approaches are equally effective when a proper marginal seal is achieved and is a highly effective technique for maintaining pulp vitality. These findings support the use of biologically based minimally invasive approaches in the management of deep carious lesions. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate the long-term performance of restorative materials in SRSD-treated teeth. Abbreviations The following abbreviations are used in this manuscript: SRSD: Selective Removal to Soft Dentin CS: Calcium Silicate NL: No Liner ESE: European Society of Endodontology AAE: American Association of Endodontists GIC: Glass Ionomer Cement IRB: Institutional Review Board FDI: Fédération Dentaire Internationale ICCC: International Caries Consensus Collaboration Er,Cr:YSGG: Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet Declarations Ethics approval and consent to participate The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Universidad Rey Juan Carlos (protocol code 0212202023220). Written informed consent was obtained from all participants prior to inclusion. Consent for publication Written informed consent for participation and publication of anonymized data was obtained from all subjects involved in the study. Availability of data and materials The data that support the findings of this study are available from the corresponding author upon reasonable request. Competing interests The authors declare no competing interests. Funding This research received no external funding. Authors’ contributions Patricia Terceño: methodology, selection and allocation of the teeth, clinical procedures, data curation, writing – original draft, writing – review and editing. Juan Gonzalo Olivieri: methodology, writing – original draft, supervision. Mª Victoria Fuentes: clinical examiner, visualization, review, supervision. Laura Ceballos: conceptualization, methodology, clinical examiner, data curation, writing – original draft, writing – review, supervision and editing. All authors have read and approved the final version of the manuscript. Acknowledgements The authors would like to thank the Fundación Clínica Universitaria de la Universidad Rey Juan Carlos for kindly providing us with the facilities to conduct the treatments. This paper is part of a thesis to be submitted in partial fulfilment of the requirements for a doctoral degree of the student of the International Doctoral School of Universidad Rey Juan Carlos, Patricia Terceño. Authors’ information Not applicable. Protocol and statistical analysis plan The protocol and statistical analysis plan are available upon request from the corresponding author. References Bjørndal L, Simon S, Tomson PL, Duncan HF. Management of deep caries and the exposed pulp. Int Endod J. 2019;52:949-73. Schwendicke F, Frencken JE, Bjørndal L, Maltz M, Manton DJ, Ricketts D, et al. Managing carious lesions: consensus recommendations on carious tissue removal. Adv Dent Res. 2016;28:58-67. Ramezanzade S, Bjørndal L, Chen H, Baysan A. 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Selective removal to soft dentine or selective removal to firm dentine for deep caries lesions in permanent posterior teeth: a randomized controlled clinical trial up to 2 years. Clin Oral Investig. 2023;27:2125-37. Blum IR, Wilson NHF. An end to linings under posterior composites? J Am Dent Assoc. 2018;149:209-13. Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, et al. European Society of Endodontology position statement: management of deep caries and the exposed pulp. Int Endod J. 2019;52:923-34. Edwards D, Bailey O, Stone S, Duncan H. The management of deep caries in UK primary care: a nationwide questionnaire-based study. Int Endod J. 2021;54:1804- Niu LN, Zhang W, Pashley DH, Breschi L, Mao J, Chen JH, et al. Biomimetic remineralization of dentin. Dent Mater. 2014;30:77-96. Kaup M, Dammann CH, Schäfer E, Dammaschke T. Shear bond strength of Biodentine, ProRoot MTA, glass ionomer cement and composite resin on human dentine ex vivo. Head Face Med. 2015;11:14. Tušas P, Camilleri J, Alksnė M, Šimoliūnas E, Drukteinis S, Urbonė EM, et al. Biocompatibility of hydraulic calcium silicate-based cement MTA Flow on human dental pulp stem cells in vitro. J Funct Biomater. 2025;16:252. Al-Ali M, Camilleri J. The scientific management of deep carious lesions in vital teeth using contemporary materials: a narrative review. Front Dent Med. 2022;3:1048137. Camilleri J. Hydration characteristics of calcium silicate cements with alternative radiopacifiers used as root-end filling materials. J Endod. 2010;36:502-8. Dawood AE, Parashos P, Wong RHK, Reynolds EC, Manton DJ. Calcium silicate-based cements: composition, properties, and clinical applications. J Investig Clin Dent. 2017;8:12195. Da Silva AF, Marques MR, Da Rosa WLO, Tarquinio SBC, Rosalen PL, Barros SP. Biological response to self-etch adhesive after partial caries removal in rats. Clin Oral Investig. 2018;22:2161-73. Duque C, Hebling J, Smith AJ, Giro EM, Oliveira MF, de Souza Costa CA. Reactionary dentinogenesis after applying restorative materials and bioactive dentin matrix molecules as liners in deep cavities prepared in nonhuman primate teeth. J Oral Rehabil. 2006;33:452-61. Asgary S, Hassanizadeh R, Torabzadeh H, Eghbal MJ. Treatment outcomes of 4 vital pulp therapies in mature molars. J Endod. 2018;44:529-35. Singh S, Mittal S, Tewari S. Effect of different liners on pulpal outcome after partial caries removal: a preliminary 12-month randomized controlled trial. Caries Res. 2019;53:547-54. Miotti LL, Vissotto C, De Nardin L, de Andrades Manjabosco B, Tuchtenhagen S, Münchow EA, et al. Does the liner material influence pulpal vitality in deep carious cavities submitted to selective caries removal? A network meta-analysis review. Clin Oral Investig. 2023;27:7143-56. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726-32. Wolters WJ, Duncan HF, Tomson PL, El-Karim I, McKenna G, Dorri M, et al. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017;50:825-9. Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, et al. FDI World Dental Federation – clinical criteria for the evaluation of direct and indirect restorations: update and clinical examples. J Adhes Dent. 2010;12:259-72. Maltz M, Garcia R, Jardim JJ, de Paula LM, Yamaguti PM, Moura MS, et al. Randomized trial of partial vs stepwise caries removal: 3-year follow-up. J Dent Res. 2012;91:1026-31. Oliveira EF, Carminatti G, Fontanella V, Maltz M. The monitoring of deep caries lesions after incomplete dentine caries removal: results after 14-18 months. Clin Oral Investig. 2006;10:134-9. Schwendicke F, Frencken JE, Bjørndal L, Maltz M, Manton DJ, Ricketts D, et al. Managing carious lesions: consensus recommendations on carious tissue removal. Adv Dent Res. 2016;28:58-67. Maltz M, Koppe B, Jardim JJ, Alves LS, de Paula LM, Yamaguti PM, et al. Partial caries removal in deep caries lesions: a 5-year multicenter randomized controlled trial. Clin Oral Investig. 2018;22:1337-43. Hashem D, Mannocci F, Patel S, Manoharan A, Brown JE, Watson TF, et al. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial. J Dent Res. 2015;94:562-8. Camilleri J, Sorrentino F, Damidot D. Investigation of the hydration and bioactivity of radiopacified tricalcium silicate cement, Biodentine and MTA Angelus. Dent Mater. 2013;29:580-93. Kunert M, Piwonski I, Hardan L, Bourgi R, Sauro S, Inchingolo F, et al. Dentine remineralisation induced by bioactive materials through mineral deposition: an in vitro study. Nanomaterials (Basel). 2024;14:274. Kunert M, Lukomska-Szymanska M. Bio-inductive materials in direct and indirect pulp capping: a review. Materials (Basel). 2020;13:1204. Laurent P, Camps J, De Méo M, Déjou J, About I. Induction of specific cell responses to a Ca3SiO5-based posterior restorative material. Dent Mater. 2008;24:1486-94. Arandi NZ, Thabet M. Minimal intervention in dentistry: a literature review on Biodentine as a bioactive pulp capping material. Biomed Res Int. 2021;2021:5569313. Banomyong D, Messer H. Two-year clinical study on postoperative pulpal complications arising from the absence of a glass-ionomer lining in deep occlusal resin-composite restorations. J Investig Clin Dent. 2013;4:265-70. Corralo DJ, Maltz M. Clinical and ultrastructural effects of different liners/restorative materials on deep carious dentin: a randomized clinical trial. Caries Res. 2013;47:243-50. Bjørndal L, Simon S, Tomson PL, Duncan HF. Management of deep caries and the thickness of remaining dentin: biological considerations. Caries Res. 2019;53:488-502. Duncan HF, Cooper PR, Smith AJ. Dissecting dentine-pulp injury and wound healing responses: consequences for regenerative endodontics. Int Endod J. 2019;52:261-6. Falacho RI, Melo EA, Marques JA, Ramos JC, Guerra F, Blatz MB. Clinical in-situ evaluation of the effect of rubber dam isolation on bond strength to enamel. J Esthet Restor Dent. 2023;35:48-55. Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020;24:979-89. Ñaupari-Villasante R, Matos TP, de Albuquerque EG, Warol F, Tardem C, Calazans FS, et al. Five-year clinical evaluation of universal adhesive applied following different bonding techniques: a randomized multicenter clinical trial. Dent Mater. 2023;39:586-94. de Paris Matos T, Perdigão J, de Paula E, Coppla F, Hass V, Scheffer RF, et al. Five-year clinical evaluation of a universal adhesive: a randomized double-blind trial. Dent Mater. 2020;36:1474-85. Polesso Patias M, Fernandes-E-Silva P, Carreño NLV, Lund RG, Piva E, da Silva AF, et al. Comparative clinical performance of universal adhesives versus etch-and-rinse and self-etch adhesives: a meta-analysis. Clin Oral Investig. 2025;29:352-60. Assis P, Silva C, Nascimento A, Anníbal H, Júnior S, Soares N, et al. Does acid etching influence the adhesion of universal adhesive systems in noncarious cervical lesions? A systematic review and meta-analysis. Oper Dent. 2023;48:373-90. Fuentes MV, Perdigão J, Baracco B, Giráldez I, Ceballos L. Effect of an additional bonding resin on the 5-year performance of a universal adhesive: a randomized clinical trial. Clin Oral Investig. 2023;27:837-48. Opdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93:943-9. Demarco FF, Corrêa MB, Cenci MS, Moraes RR, Opdam NJ. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28:87-101. Mjör IA. Clinical diagnosis of recurrent caries. J Am Dent Assoc. 2005;136:1426-33. Jardim JJ, Mestrinho HD, Koppe B, de Paula LM, Alves LS, Yamaguti PM, et al. Restorations after selective caries removal: 5-year randomized trial. J Dent. 2020;99:103416. Recchi AF, Azambuja RS, Alves LS, Maltz M, Jardim JJ. Restorations performance after selective caries removal to soft dentine: 18-month follow-up of a controlled clinical trial. J Dent. 2024;147:105099. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 26 Feb, 2026 Read the published version in BMC Oral Health → Version 1 posted Editorial decision: Revision requested 11 Nov, 2025 Reviews received at journal 11 Nov, 2025 Reviews received at journal 06 Nov, 2025 Reviews received at journal 31 Oct, 2025 Reviewers agreed at journal 27 Oct, 2025 Reviewers agreed at journal 25 Oct, 2025 Reviewers agreed at journal 24 Oct, 2025 Reviewers invited by journal 23 Oct, 2025 Editor assigned by journal 23 Oct, 2025 Editor invited by journal 14 Oct, 2025 Submission checks completed at journal 13 Oct, 2025 First submitted to journal 13 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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06:29:13","extension":"xml","order_by":7,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":142425,"visible":true,"origin":"","legend":"","description":"","filename":"6b178516ccae4c1f9232694de790e8bf1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7786121/v1/d7fa6978cfb156ca6bbce457.xml"},{"id":95170662,"identity":"39b29930-e7e8-408e-8d0b-86d4539659aa","added_by":"auto","created_at":"2025-11-05 06:29:13","extension":"html","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":150880,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7786121/v1/eac07d1cdb98f5d92458bda5.html"},{"id":95170653,"identity":"b51eec34-f78f-47e7-8562-7f9f8b1793cd","added_by":"auto","created_at":"2025-11-05 06:29:13","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":96286,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram indicating patient recruitment and follow-up.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLegend: CONSORT flow diagram indicating patient enrollment, randomization, allocation, and follow-up at 1, 6, and 12 months. N\u003csub\u003er\u003c/sub\u003e: = number of restorations; N\u003csub\u003ep\u003c/sub\u003e = number of patients.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7786121/v1/1b7d9082acf38277937f6314.png"},{"id":95226364,"identity":"0a3d9b71-8372-40c8-8193-c3bdc6e10fed","added_by":"auto","created_at":"2025-11-05 16:31:03","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":2561836,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eExample radiographs of a clinical case from each treatment group.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(a) Initial bitewing radiograph of tooth 4.7 in an 18-year-old patient, showing a deep occlusal carious lesion associated with reversible pulpitis (mild pulpitis). (b) Postoperative bitewing radiograph of tooth 4.7 after selective removal to soft dentin (SRSD), with Biodentine™ used as a liner. (c) Twelve-month follow-up bitewing radiograph of tooth 4.7. (d) Initial bitewing radiograph of tooth 3.7 in the same patient, showing a deep occlusal carious lesion associated with reversible pulpitis (mild pulpitis). (e) Postoperative bitewing radiograph of tooth 3.7 after SRSD, restored without the use of a liner (direct adhesive procedure). (f) Twelve-month follow-up bitewing radiograph of tooth 3.7.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7786121/v1/b4bd6b5ce1e1cdc3d6e021e3.png"},{"id":103765541,"identity":"5ba47a9f-68e7-4b47-9f3a-826fdb347efc","added_by":"auto","created_at":"2026-03-02 16:03:47","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3837606,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7786121/v1/9a1ea0ec-1457-4046-912b-16d72461e13c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Calcium Silicate Liner versus No Liner in Selective Caries Removal: A One-year Randomized Clinical Trial","fulltext":[{"header":"1.Background","content":"\u003cp\u003eThanks to better understanding of the physiology of the dentin\u0026ndash;pulp complex and its re-sponse capacity, modern conservative dentistry prioritizes preserving pulpal health to maintain its developmental and defensive properties [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThis principle is critical when treating deep carious lesions, defined as those reaching the inner quarter of dentin and presenting a risk of pulp exposure during operative treatment, although radiographically a zone of sound dentin between caries and pulp can still be detected1. To manage these deep lesions, two treatments are currently accepted according to the International Caries Consensus Collaboration (ICCC): stepwise removal (SW) or selective removal to soft dentin (SRSD) [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. These techniques aim to minimize pulp exposure and allow the dentin\u0026ndash;pulp complex to activate its defense mechanisms [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe SW technique was the one originally described to deal with deep carious lesions and shares with SRSD an incomplete removal of caries tissue to promote tertiary dentin formation. The difference is that SW involves a two-stage procedure. The cavity is sealed with a temporary filling and reopened, between 6 and 12 months later, to perform the removal of the remaining demineralized dentin and place a definitive restoration [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. However, recent evidence questions the need for a second stage, highlighting that re-entry may be unnecessary, reducing costs, discomfort, and the risk of patients not returning [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Hence, the single-visit SRSD approach is now widely recommended [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSRSD consists of leaving a layer of soft carious tissue over the floor on the pulpal aspect of the cavity while removing peripheral caries to hard dentin consistency, to ensure an adequate bonding substrate to achieve a hermetic seal with the restoration [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Consequently, nutrient supply to bacteria is interrupted, the pH lesion modified, the toxins reduced and tertiary dentin formation and dentinal tubule sclerosis are promoted, favouring remineralization [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Without the obligation to eradicate the entire bacterial population, the need for removal of larger amounts of tissue is reduced and so it is the risk of pulp exposure [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. The clinical success rates reported for SRSD in deep lesions are high, ranging between 84% and 100% with predictable long-term results [\u003cspan additionalcitationids=\"CR11\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe use of a biologically based material for indirect pulp capping has been recommended for therapeutic reasons as the dentin thickness over the pulp cannot be accurately assessed clinically [\u003cspan additionalcitationids=\"CR14\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. According to the position statement of the European Society of Endodontology (ESE), a hydraulic calcium silicate would be the material of choice, with the possibility of using also a conventional glass\u0026ndash;ionomer cement [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eHydraulic calcium silicate cements offer several advantages: they are highly biocompatible, reduce the risk of adverse tissue reactions provide antimicrobial properties due to their high alkalinity, and also offer excellent marginal sealing due to slight expansion upon setting, minimizing the risk of microleakage [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Additionally, they release beneficial ions such as calcium and silicate, supporting tissue mineralization [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Their dimensional stability, mechanical strength, and radiopacity further contribute to their effectiveness and clinical reliability [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAmong them, Biodentine\u0026trade; (Septodont, St. Maur-des-Foss\u0026eacute;s, France) was developed as a calcium silicate-based material offering easier handling, shorter setting time, lower risk of tooth discoloration, and improved cost-effectiveness [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. It is one of the most studied calcium silicate-based cements (also known as \u0026ldquo;smart dentin replacement\u0026rdquo;), composed of tricalcium silicate, calcium carbonate, and zirconium oxide in its powder phase, with a water-based liquid containing calcium chloride as setting accelerator and water-reducing agent [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Despite its excellent properties, Biodentine\u0026trade;, as well as calcium silicate cements in general, present other issues that have limited their adoption in clinical practice. These include high cost, difficulty of application, lack of intrinsic adhesion to dentin and to the restorative material, long setting time and the potential risk of tooth discoloration [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Given these drawbacks, robust clinical evidence is essential to justify their use and to confirm that they offer a tangible benefit in improving treatment outcomes.\u003c/p\u003e\u003cp\u003eClinical, radiographic, and microbiological evaluations have demonstrated that achieving a hermetic seal alone can inactivate active deep carious lesions [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Moreover, self-etch adhesives also stimulate early pulp repair after selective removal of carious tissue [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Therefore, a good marginal seal may be sufficient to control caries progression, without necessarily attributing a major role to the lining material [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eMost clinical studies evaluating SRSD technique have used different liner materials such as glass ionomer cement, calcium hydroxide, Biodentine\u0026trade; or MTA [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. However, very few have explored this technique without any liner material [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Therefore, more clinical trials are needed to investigate whether the use of a calcium silicate-based material is truly essential to enhance the success rate of the SRSD technique [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAccordingly, the aim of the present study was to compare the clinical and radiographic success of SRSD using a calcium silicate-based liner versus a direct adhesive procedure in permanent posterior teeth restored with resin composite after 1 year. The null hypothesis for this study was that there is no difference in success rate when comparing SRSD with and without a calcium silicate-based liner in permanent posterior teeth with deep carious lesions.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cp\u003e\u003cstrong\u003e2.1. Study Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis was a prospective, parallel group, randomized controlled clinical trial with a 1:1 allocation ratio. The study was approved by the University Ethics Committee (protocol code 0212202023220) and registered at ClinicalTrials.gov (Identifier: NCT04743219). This study was conducted in accordance with the CONSORT (Consolidated Standards of Re-porting Trials) guidelines [27]. Written informed consent was obtained from all participants prior to inclusion, and from the parents or legal guardians of participants under the age of 16. Recruitment and follow-up took place at the University Dental Clinic between February 2021 and May 2024.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2. Participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients aged over 14 years who attended the University Dental Clinic were consecutively screened for eligibility. The following variables were recorded: sociodemographic data, tooth type (premolar or molar; maxillary or mandibular), caries lesion extension, pulpal diagnosis and caries risk. Caries risk was determined using the Cariogram software (Malm\u0026ouml; University, Sweden), categorizing patients into high (0\u0026ndash;20%), moderate (21\u0026ndash;80%), or low (\u0026gt;80%) probability of avoiding new cavities.\u003c/p\u003e\n\u003cp\u003eInclusion Criteria:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePermanent posterior teeth with deep carious lesions radiographically extending at least two-thirds into dentin.\u003c/li\u003e\n \u003cli\u003eA radiographically visible band of sound dentin separating the carious lesion from the pulp chamber roof.\u003c/li\u003e\n \u003cli\u003ePositive response to cold testing (\u0026ndash;50 \u0026deg;C Roeko Endo-Frost, Colt\u0026egrave;ne, Germany) indicating normal pulp or mild reversible pulpitis (sensibility or pain lasting up to 15 - 20 seconds and settling spontaneously) [28].\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTeeth had to be restorable with a direct restoration.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eExclusion criteria:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eTeeth with spontaneous pain, prolonged response for more than 20 seconds to cold testing, persistent dull throbbing pain and tenderness to percussion or pain exacerbated [28].\u003c/li\u003e\n \u003cli\u003ePatients with persistent periodontal disease, pregnant or lactating, with systemic illness, immunosuppression, or allergy to study materials.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e2.3. Sample Size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size was determined by convenience based on the number of eligible patients during the recruitment period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.4. Randomization and Allocation Concealment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRandomization was performed using a computer-generated random sequence (www.randomizer.org) with equal allocation to two experimental groups. Allocation was managed by the principal investigator, who was the only individual aware of the sequence. Due to the nature of the intervention, the operator could not be blinded, but both patients and outcome examiners were blinded to group assignment.\u003c/p\u003e\n\u003cp\u003eA single operator performed patient screening, including clinical and radiographic examinations. Standardized bitewing and periapical preoperative radiographs were obtained using the same digital imaging system (RVG 6200, Carestream Health, USA).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5. Interventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures were performed under local anesthesia and rubber dam isolation by a single experienced operator (8 years of clinical practice). Carious dentin was removed with low-speed tungsten carbide burs (H1, Komet Dental, Lemgo, Germany) and manual excavators until hard dentin was reached peripherally, preserving a layer of soft dentin on the pulpal floor to avoid pulp exposure.\u003c/p\u003e\n\u003cp\u003eAccording to randomization, the teeth were allocated to the following groups after se-lective caries removal to soft dentin (SRSD):\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eCS Group (Calcium Silicate Liner):\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eBiodentine\u0026trade; (Septodont) was mixed for 30 seconds, following manufacturer\u0026rsquo;s instructions and placed in a 2 mm layer over the pulpal floor.\u003c/p\u003e\n\u003cp\u003eAfter a 12-minute setting time, selective enamel etching was performed with 3M\u0026trade; Scotchbond\u0026trade; Universal Etchant (Solventum, Maplewood, Minnesota, USA) for 30 sec-onds. 3M\u0026trade; Scotchbond\u0026trade; Universal Plus adhesive (Solventum) was actively applied for 20 seconds, air-thinned, and light-cured for 20 seconds (SmartLite Pro, Dentsply Sirona Charlotte, North Carolina, U.S.; 1250 mW/cm\u0026sup2;). The cavity was restored incrementally with Ceram.X Universal composite (Dentsply Sirona) and each 2 mm layer was light-cured for 20 seconds.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eNL Group (No Liner):\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eNo liner was placed. An identical adhesive protocol as the described above for CS group was carried out directly on dentin and enamel, followed by restoration with Ceram.X Universal composite using the same technique.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.6. Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcomes were clinical and radiographic treatment success. Clinical success was defined as: absence of symptoms (no spontaneous pain or lingering sensitivity), positive response to pulp sensibility tests within normal limits, no clinical signs of inflammation or infection (e.g., swelling, sinus tract, abscess) [14].\u003c/p\u003e\n\u003cp\u003eRadiographic success required no evidence of apical periodontitis or periodontal ligament space widening and no pathological internal or external root resorption [14].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSecondary outcome included direct resin composite restoration performance according to the FDI criteria (esthetic, functional, and biological properties) [29]. For statistical analysis, categories 1 and 2 were grouped as \u0026ldquo;clinically acceptable,\u0026rdquo; whereas scores \u0026ge;3 were considered \u0026ldquo;clinically unacceptable.\u0026rdquo; Restorations rated as \u0026ldquo;clinically unsatisfactory\u0026rdquo; or \u0026ldquo;poor\u0026rdquo; in any category were considered failures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.7. Follow-Up\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients were evaluated clinically at 1 and 6 months by the operator and 12 months postoperatively by two blinded, calibrated examiners. Standardized bitewing and per-iapical radiographs were taken immediately after treatment and at 6- and 12-month recalls using film holders and the XCP-DS positioner system (Carestream Health). Ra-diographs were withheld from the examiners until completion of the clinical assessments to ensure blinding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8. Statistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analysis was performed using the openxlsx3 v.4.2.5 package in the R envi-ronment. The primary outcome was success/failure of each treated tooth (binary variable: maintained or lost vitality at 1 year). The tooth was considered the primary unit of analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eContinuous variables (age) were expressed as mean and standard deviation (SD) or median and interquartile range (IQR), while categorical variables (gender, tooth type, cavity type, probability of avoiding new cavities and pulpal diagnosis,) were expressed as absolute and relative frequencies.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eComparisons between groups were performed using the Wilcoxon test for continuous variables and Fisher\u0026rsquo;s exact test for categorical variables.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll p-values were adjusted using the false discovery rate (FDR) method to account for multiple comparisons, with a significance level set at \u0026alpha; = 0.05.\u003c/p\u003e"},{"header":"3. Results","content":"\u003cp\u003e\u003cstrong\u003e3.1 Participant Flow and Baseline Characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 45 teeth from 32 patients, with ages between 15 and 62 years, met the inclusion criteria and were randomized. Details of patient flow, allocation, and follow-up are illustrated in Figure 1.\u003c/p\u003e\n\u003cp\u003eAt the 12-month recall, the CS group showed 4 lost restorations (17.4%) compared with 8 (36.4%) in the NL group. Similarly, 3 patients (15.8%) were lost in the CS group versus 5 (38.5%) in the NL group. Although the proportion of losses was almost twice as high in the NL group, Fisher\u0026rsquo;s exact test revealed no statistically significant differences between groups for restorations (p = 0.189) or patients (p = 0.219).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.2 Descriptive Analysis of Treated Teeth\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe mean age of participants in the CS group was 25.74 years (SD = 10.7), while the NL group presented a mean age of 22.86 years (SD = 5.5). The difference between groups was not statistically significant (p = 0.592). The distribution of gender did not differ significantly between groups, with 78.3% females in the CS group versus 63.6% in the NL group (p = 0.337). Similarly, the probability of avoiding new caries was 23.9% in the NL group versus 19.2% in the CS group; the difference was not statistically significant (p = 0.439). Table 1 presents the baseline characteristics of the treated teeth according to the assigned treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e \u003cstrong\u003eDescription of baseline characteristics by treatment group.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eVariable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eCS, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eNL, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eTooth Type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.437\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Maxil. premolars\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e12 (52.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e7 (31.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Maxil. molars\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e3 (13%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2 (9.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Mand. premolars\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e1 (4.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2 (9.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Mand. molars\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e7 (30.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e11 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eCavity Type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.113\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Occlusal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e6 (26.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5 (22.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Occluso-mesial\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4 (17.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e5 (22.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Occluso-distal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e13 (56.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e12 (54.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003ePulp Diagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.357\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Normal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e9 (39.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e15 (68.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp; Reversible pulpitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e14 (60.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e7 (31.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eLegend: CS = calcium silicate liner; NL = no liner.\u003c/p\u003e\n\u003cp\u003eThere were no statistically significant between the test and the control groups regarding tooth, cavity defect and preoperative pulp diagnosis (p\u0026gt;0.05). The analysis of cohort homogeneity did not find significant differences depending on the material used.\u003c/p\u003e\n\u003cp\u003eMoreover, most teeth (95.6%) exhibited physiological probing depths, nearly 98% had an opposing antagonist tooth, and 93% had adjacent teeth present. A balanced distribution across groups was present.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.3 Success Rate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth groups demonstrated a 100% success rate after 12 months, as all evaluated teeth exhibited a normal pulp response to cold testing, a negative percussion response, patients were asymptomatic, radiographically normal periapical structures were seen and 97% had physiologic probing depth. Therefore, no significant difference was observed between the group treated with Biodentine\u003csup\u003eTM\u003c/sup\u003e and the group without a liner. No failures or adverse events were recorded.\u003c/p\u003e\n\u003cp\u003eAt the 12-month follow-up, according to the FDI World Dental Federation criteria [29], both groups demonstrated high clinical performance, with most of the restorations rated as clinically excellent or good. Comprehensive details regarding the evaluation of the restorations are provided in Table 2.\u003c/p\u003e\n\u003cp\u003eNo statistically significant differences were found between CS and NL groups in surface luster, colour match and translucency, marginal staining, or other esthetic, biological, and functional parameters (p \u0026gt; 0.05). The only exception was anatomical form, in which the NL group scored 100% acceptable compared with 89% in the CS group, a difference that reached statistical significance (p = 0.001). Overall, the clinical performance of restorations was comparable between the two groups after 12 months of follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2. Restoration evaluation by assigned treatment.\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 178px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"5\" style=\"width: 138px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGROUP CS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"5\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGROUP NL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 66px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 66px;\"\u003e\n \u003cp\u003eAesthetic properties\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eSurface luster\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e26%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e68%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e36%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eSurface staining\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e95%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e86%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e14%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eMarginal staining\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e89%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e11%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e93%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eColour match and translucency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e42%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e47%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e11%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e36%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e14%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"9\" style=\"width: 66px;\"\u003e\n \u003cp\u003eFunctional properties\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eAnatomical form\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e47%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e42%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e11%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e29%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e71%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eFracture and retention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e79%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e16%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e86%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e14%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eMarginal adaptation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e58%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e37%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e57%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e43%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eOcclusal contour and wear qualitatively\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eOcclusal contour and wear quantitatively\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eApproximal anatomical form contact point\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e78%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e6%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e46%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e15%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eApproximal anatomical form contour\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e33%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e46%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e8%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e8%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eRadiographic examination (when applicable)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e95%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003ePatient\u0026rsquo;s view\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"6\" style=\"width: 66px;\"\u003e\n \u003cp\u003eBiological properties\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003ePostoperative (hyper-) sensitivity and tooth vitality\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eRecurrence of caries, erosion, abfraction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eTooth integrity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003ePeriodontal response (always compared to reference tooth)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e93%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eAdjacent mucosa\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eOral and general health\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 24px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 29px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eLegend: Evaluated according to the FDI World Dental Federation criteria using a 5-point scale: 1 = clinically excellent, 2 = clinically good, 3 = clinically sufficient/satisfactory, 4 = clinically unsatisfactory, 5 = clinically poor (percentages). CS = calcium silicate liner; NL = no liner.\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThe results of this randomized controlled clinical trial showed that SRSD in deep carious lesions with normal or reversible pulpitis achieved a 100% clinical and radiographic success rate at 12-month follow-up, regardless of whether a calcium silicate-based liner was used. Therefore, the null hypothesis must be accepted.\u003c/p\u003e\u003cp\u003eSRSD is considered and effective approach for managing deep carious lesions in vital permanent teeth without signs of irreversible pulpitis [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In agreement, our results have demonstrated that SRSD can successfully maintain pulpal health even when soft, de-mineralized dentin was intentionally retained, reinforcing the biological foundation and clinical value of minimally invasive approaches in managing deep carious lesions. This study is consistent with a recent study by G\u0026ouml;zetici et al. which reported 100% success with the SRSD technique [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Similarly, long-term clinical trials by Maltz et al. have demonstrated success rates of 90\u0026ndash;91% over 3\u0026ndash;10 years, supporting the reliability of SRSD in maintaining pulp vitality [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eMoreover, SRSD has been associated with a significantly lower risk of pulp exposure compared to non-selective excavation [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] for which reason it has been considered the preferred treatment option when carious lesions extend beyond two-thirds of the dentin [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In line with this, no cases of pulp exposure were observed in our study, further supporting this assertion.\u003c/p\u003e\u003cp\u003eOur analysis also revealed that gender and tooth type had no influence on treatment outcomes, consistent with previous studies [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Patient age was also not relevant; our youngest patient was 15 and the oldest 62, with no significant differences between them, corroborating earlier reports [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOne of the most debated aspects of the SRSD is the selection of a liner material. Bio-dentine\u0026trade; strengthens pulpal defense, promotes dentin remineralization, ensures long-term biocompatibility without compromising aesthetics and stimulates odontoblastic activity [\u003cspan additionalcitationids=\"CR36 CR37\" citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Its excellent clinical performance has been demonstrated in multiple longitudinal studies, with success rates of approximately 96\u0026ndash;100% at 12 months and values close to 92% at three-year follow-up [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. However, whether the use of a calcium silicate\u0026ndash;based liner is essential for improving the success rate of SRSD has not been proved.\u003c/p\u003e\u003cp\u003eIn the present randomized controlled trial, the use or omission of a calcium silicate\u0026ndash;based liner, specifically Biodentine\u0026trade;, did not significantly influence the clinical or radiographic success of the SRSD technique after 12 months. These findings are consistent with previous studies reporting that the absence of a liner did not increase the risk of pulpal complications in deep occlusal cavities [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]. Similarly, G\u0026ouml;zetici et al also observed no detrimental impact on success rates when a liner was not applied [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Corralo et al., 2013 further confirmed that clinical success (no clinical symptoms or radiographic signs of pulpitis or necrosis) could be achieved without a cavity liner, demonstrating comparable outcomes when different liners were tested against inert wax following partial caries removal in permanent teeth with deep lesions [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. Importantly, regardless of the liner used, adequate sealing proved crucial, as it was consistently associated with dentin hardening, reduced bacterial contamination, and dentin reorganization [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe thickness of remaining dentin seems to influence the most in the nature and extent of dentin repair, as a sufficient dentin barrier protects the pulp from irritants and allows odontoblasts to reactivate their healing potential and deposit reactionary tertiary dentin once bacterial load is reduced and an adequate seal is established [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. In our study, particular care was taken during case selection to ensure that an appropriate dentin thickness was preserved, which may account for the favorable outcomes obtained. This highlights that the clinical success of SRSD depends less on the choice of liner material than on maintaining sufficient dentin to protect pulpal vitality, further supporting the notion that sealing quality and residual dentin thickness are the true determinants of long-term success.\u003c/p\u003e\u003cp\u003eWithin this context, the routine use of materials like Biodentine\u0026trade; should be justified by clear clinical benefits. To date, such benefits have not been conclusively demonstrated, especially considering its higher cost, longer setting time, and lack of adhesion to both tooth structure and composite resin; factors that complicate its placement, particularly in narrow upper premolar cavities, as previously reported by G\u0026ouml;zetici et al [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe success of vital pulp treatments has been closely associated with the meticulous ex-ecution of the restorative procedure, as achieving an optimal marginal seal in the same clinical session is essential. To ensure this, all interventions were performed under ab-solute isolation with a rubber dam, as recommended by ESE [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. This approach mini-mizes bacterial contamination, enhances adhesive performance, reduces postoperative sensitivity, and contributes to a more predictable and durable marginal seal [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. However, while most studies employed rubber dam isolation during procedures [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]; favorable outcomes have also been reported without it. Banomyong et al. observed no pulpal complications after 2 years, Koc Vural et al. who reported 82.9% retention at 5 years, and G\u0026ouml;zetici et al. who achieved 100% success [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe adhesive procedure, which is key to achieving a stable long-term marginal seal, was performed using a universal adhesive system. This type of adhesives has been shown to perform very well in clinical settings, with several studies reporting high success rates and restoration durability over a 5-year period [\u003cspan additionalcitationids=\"CR47\" citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. The presence of enamel is con-sidered fundamental for the long-term success of adhesive restorations. Enamel provides a highly mineralized and stable substrate that enables durable micromechanical retention and stronger bonding compared to dentin [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]. For this reason, particular emphasis was placed on preserving enamel whenever possible during cavity preparation. The adhesive was applied using a selective enamel etching technique, which combines phosphoric acid application on enamel with self-etching on dentin. This approach has been associated with improved marginal adaptation and reduced discoloration, thereby enhancing the longevity and stability of the adhesive interface [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eWith respect to restoration outcomes, all restorations remained functional and symp-tom-free and were clinically acceptable according to FDI criteria with no significant dif-ferences between the CS and NL groups [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. This should be interpreted with caution given the relatively short observation period of 12 months, which may be insufficient to detect changes in composite restorations over time. Additionally, cavity type did not influence the clinical or radiographic success of the treatment, in agreement with Maltz et al. and G\u0026ouml;zetici et al. [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. The longevity of restorations is not only determined by the restorative material and operative technique, but also by patient- and tooth-related factors. Larger restorations are more prone to failure due to higher stress distribution and reduced residual tooth structure, which can compromise marginal integrity and lead to secondary complications [\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e, \u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e]. In addition, patients with a high caries risk present a greater likelihood of developing recurrent lesions adjacent to restorations, which negatively impacts their long-term survival [\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e]. In the present study, participants will continue to be monitored, as the 12-month follow-up represents only a short-term evaluation. Longer observation periods are needed to provide more robust evidence regarding the influence of restoration size and caries risk on clinical outcomes.\u003c/p\u003e\u003cp\u003eFew clinical trials have evaluated the long-term outcomes of restorations after SRSD is performed in permanent teeth. The available studies consistently support its success, demonstrating favorable outcomes over time [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e]. In addition, our findings are in agreement with previous evidence showing that the type of liner placed beneath the restoration does not play a decisive role in treatment success, as sealing ability rather than liner selection appears to be the critical factor for long-term survival [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite these promising results, several limitations must be acknowledged. First, the relatively small sample size and the limited observation period of 12 months restrict the strength of the conclusions. Second, the high dropout rate observed during follow-up reflects the inherent challenges of prospective dental research; in our study, a possible explanation is that patients perceived the procedure as routine and underestimated the importance of attending follow-up appointments. Finally, the fact that the study was conducted under highly controlled university conditions may limit the generalizability of the findings.\u003c/p\u003e\u003cp\u003eAt the same time, the study also presents important strengths, including strict ran-domization, clearly defined inclusion criteria, and standardized treatment delivered by a single operator, which enhance the internal validity of the results. Furthermore, clinical trials provide valuable insights that laboratory investigations\u0026mdash;constrained by their lack of biological and behavioural variability\u0026mdash;cannot fully capture.\u003c/p\u003e\u003cp\u003eFuture research with larger sample sizes, longer follow-up periods, and evaluations in broader clinical settings is required to validate these findings and further consolidate the evidence base for SRSD.\u003c/p\u003e"},{"header":"5. Conclusions","content":"\u003cp\u003eAt 12 months, selective removal of carious tissue to soft dentin (SRSD) in deep lesions with normal or reversible pulpitis demonstrated clinical and radiographic success rates identical between teeth treated with a calcium silicate\u0026ndash;based liner and those restored directly with an adhesive procedure, indicating that both approaches are equally effective when a proper marginal seal is achieved and is a highly effective technique for maintaining pulp vitality.\u003c/p\u003e\u003cp\u003eThese findings support the use of biologically based minimally invasive approaches in the management of deep carious lesions. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate the long-term performance of restorative materials in SRSD-treated teeth.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eThe following abbreviations are used in this manuscript:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eSRSD: Selective Removal to Soft Dentin\u003c/li\u003e\n \u003cli\u003eCS: Calcium Silicate\u003c/li\u003e\n \u003cli\u003eNL: No Liner\u003c/li\u003e\n \u003cli\u003eESE: European Society of Endodontology\u003c/li\u003e\n \u003cli\u003eAAE: American Association of Endodontists\u003c/li\u003e\n \u003cli\u003eGIC: Glass Ionomer Cement\u003c/li\u003e\n \u003cli\u003eIRB: Institutional Review Board\u003c/li\u003e\n \u003cli\u003eFDI: F\u0026eacute;d\u0026eacute;ration Dentaire Internationale\u003c/li\u003e\n \u003cli\u003eICCC: International Caries Consensus Collaboration\u003c/li\u003e\n \u003cli\u003eEr,Cr:YSGG: Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Universidad Rey Juan Carlos (protocol code 0212202023220). Written informed consent was obtained from all participants prior to inclusion.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent for participation and publication of anonymized data was obtained from all subjects involved in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from the corresponding author upon reasonable request.\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\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no external funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatricia Terce\u0026ntilde;o: methodology, selection and allocation of the teeth, clinical procedures, data curation, writing \u0026ndash; original draft, writing \u0026ndash; review and editing.\u003c/p\u003e\n\u003cp\u003eJuan Gonzalo Olivieri: methodology, writing \u0026ndash; original draft, supervision.\u003c/p\u003e\n\u003cp\u003eM\u0026ordf; Victoria Fuentes: clinical examiner, visualization, review, supervision.\u003c/p\u003e\n\u003cp\u003eLaura Ceballos: conceptualization, methodology, clinical examiner, data curation, writing \u0026ndash; original draft, writing \u0026ndash; review, supervision and editing.\u003c/p\u003e\n\u003cp\u003eAll authors have read and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank the Fundaci\u0026oacute;n Cl\u0026iacute;nica Universitaria de la Universidad Rey Juan Carlos for kindly providing us with the facilities to conduct the treatments. This paper is part of a thesis to be submitted in partial fulfilment of the requirements for a doctoral degree of the student of the International Doctoral School of Universidad Rey Juan Carlos, Patricia Terce\u0026ntilde;o.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProtocol and statistical analysis plan\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol and statistical analysis plan are available upon request from the corresponding author.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eBj\u0026oslash;rndal L, Simon S, Tomson PL, Duncan HF. Management of deep caries and the exposed pulp. Int Endod J. 2019;52:949-73.\u003c/li\u003e\n \u003cli\u003eSchwendicke F, Frencken JE, Bj\u0026oslash;rndal L, Maltz M, Manton DJ, Ricketts D, et al. 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Biomed Res Int. 2021;2021:5569313.\u003c/li\u003e\n \u003cli\u003eBanomyong D, Messer H. Two-year clinical study on postoperative pulpal complications arising from the absence of a glass-ionomer lining in deep occlusal resin-composite restorations. J Investig Clin Dent. 2013;4:265-70.\u003c/li\u003e\n \u003cli\u003eCorralo DJ, Maltz M. Clinical and ultrastructural effects of different liners/restorative materials on deep carious dentin: a randomized clinical trial. Caries Res. 2013;47:243-50.\u003c/li\u003e\n \u003cli\u003eBj\u0026oslash;rndal L, Simon S, Tomson PL, Duncan HF. Management of deep caries and the thickness of remaining dentin: biological considerations. Caries Res. 2019;53:488-502.\u003c/li\u003e\n \u003cli\u003eDuncan HF, Cooper PR, Smith AJ. Dissecting dentine-pulp injury and wound healing responses: consequences for regenerative endodontics. Int Endod J. 2019;52:261-6.\u003c/li\u003e\n \u003cli\u003eFalacho RI, Melo EA, Marques JA, Ramos JC, Guerra F, Blatz MB. Clinical in-situ evaluation of the effect of rubber dam isolation on bond strength to enamel. J Esthet Restor Dent. 2023;35:48-55.\u003c/li\u003e\n \u003cli\u003eKoc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020;24:979-89.\u003c/li\u003e\n \u003cli\u003e\u0026Ntilde;aupari-Villasante R, Matos TP, de Albuquerque EG, Warol F, Tardem C, Calazans FS, et al. Five-year clinical evaluation of universal adhesive applied following different bonding techniques: a randomized multicenter clinical trial. Dent Mater. 2023;39:586-94.\u003c/li\u003e\n \u003cli\u003ede Paris Matos T, Perdig\u0026atilde;o J, de Paula E, Coppla F, Hass V, Scheffer RF, et al. Five-year clinical evaluation of a universal adhesive: a randomized double-blind trial. Dent Mater. 2020;36:1474-85.\u003c/li\u003e\n \u003cli\u003ePolesso Patias M, Fernandes-E-Silva P, Carre\u0026ntilde;o NLV, Lund RG, Piva E, da Silva AF, et al. Comparative clinical performance of universal adhesives versus etch-and-rinse and self-etch adhesives: a meta-analysis. Clin Oral Investig. 2025;29:352-60.\u003c/li\u003e\n \u003cli\u003eAssis P, Silva C, Nascimento A, Ann\u0026iacute;bal H, J\u0026uacute;nior S, Soares N, et al. Does acid etching influence the adhesion of universal adhesive systems in noncarious cervical lesions? A systematic review and meta-analysis. Oper Dent. 2023;48:373-90.\u003c/li\u003e\n \u003cli\u003eFuentes MV, Perdig\u0026atilde;o J, Baracco B, Gir\u0026aacute;ldez I, Ceballos L. Effect of an additional bonding resin on the 5-year performance of a universal adhesive: a randomized clinical trial. Clin Oral Investig. 2023;27:837-48.\u003c/li\u003e\n \u003cli\u003eOpdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93:943-9.\u003c/li\u003e\n \u003cli\u003eDemarco FF, Corr\u0026ecirc;a MB, Cenci MS, Moraes RR, Opdam NJ. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28:87-101.\u003c/li\u003e\n \u003cli\u003eMj\u0026ouml;r IA. Clinical diagnosis of recurrent caries. J Am Dent Assoc. 2005;136:1426-33.\u003c/li\u003e\n \u003cli\u003eJardim JJ, Mestrinho HD, Koppe B, de Paula LM, Alves LS, Yamaguti PM, et al. Restorations after selective caries removal: 5-year randomized trial. J Dent. 2020;99:103416.\u003c/li\u003e\n \u003cli\u003eRecchi AF, Azambuja RS, Alves LS, Maltz M, Jardim JJ. Restorations performance after selective caries removal to soft dentine: 18-month follow-up of a controlled clinical trial. J Dent. 2024;147:105099.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-oral-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ohea","sideBox":"Learn more about [BMC Oral Health](http://bmcoralhealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ohea/default.aspx","title":"BMC Oral Health","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Selective Caries Removal, Calcium Silicate Cements, Dental Caries, Dental Pulp, Clinical trial, Treatment Outcome","lastPublishedDoi":"10.21203/rs.3.rs-7786121/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7786121/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground/Objectives:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSelective removal to soft dentine (SRSD) is recommended to minimize pulp exposure in deep carious lesions. The use of calcium silicate-based liners has been advocated to en-hance pulp protection; however, their true clinical benefit remains controversial. This study aimed to compare the clinical and radiographic success of the SRSD technique with and without the use of a bioactive liner in permanent posterior teeth with closed apex after 12 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA double-blind, randomized controlled trial was conducted in patients aged 15–62 years with deep carious lesions in posterior permanent teeth with normal or reversible pulpitis. Teeth were randomly assigned to two groups: application of a hydraulic calcium silicate-based cement (Biodentine™) or no liner (direct adhesive procedure). All restorations were performed under rubber dam isolation. The primary outcome was treatment success (maintained or lost vitality at 12 months), with the tooth as the unit of analysis. Success was defined as absence of symptoms, normal pulp sensibility response, no clinical signs of inflammation or infection and absence of periapical pathology on radiographs. Continuous and categorical variables were compared using Wilcoxon and Fisher’s exact tests, respectively, with FDR-adjusted p-values (α = 0.05).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 45 teeth in 32 patients were treated, with 33 teeth available for 12-month fol-low-up. Both groups achieved 100% success rates with no statistically significant differ-ences. All teeth maintained normal pulp responses, were asymptomatic, and showed healthy periapical structures. Restoration quality was acceptable according to FDI criteria, with no failures or adverse events recorded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter 12 months, the use of a calcium silicate-based liner did not significantly impact the clinical or radiographic success of the SRSD technique in deep caries lesions. A direct adhesive approach without a liner may be a reliable, simpler, and cost-effective alter-native for maintaining pulp vitality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e The study was approved by the University Ethics Committee (protocol code 0212202023220) and registered at ClinicalTrials.gov (Identifier: NCT04743219; date of registration: February 5, 2021).\u003c/p\u003e","manuscriptTitle":"Calcium Silicate Liner versus No Liner in Selective Caries Removal: A One-year Randomized Clinical Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-05 06:29:08","doi":"10.21203/rs.3.rs-7786121/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-11-11T11:12:31+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-11T05:41:01+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-06T14:33:10+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-31T11:39:54+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"181440816230453825784100931720383328742","date":"2025-10-27T10:23:57+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"228934067407840487435097541005164913164","date":"2025-10-25T15:12:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"97041025086864557378541099990913072921","date":"2025-10-24T17:13:18+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-23T04:36:52+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-23T04:24:30+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-14T17:28:48+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-13T06:02:39+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Oral Health","date":"2025-10-13T05:36:12+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-oral-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ohea","sideBox":"Learn more about [BMC Oral Health](http://bmcoralhealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ohea/default.aspx","title":"BMC Oral Health","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e66e356f-f2cb-4873-9138-e1fdbabf35a4","owner":[],"postedDate":"November 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:01:16+00:00","versionOfRecord":{"articleIdentity":"rs-7786121","link":"https://doi.org/10.1186/s12903-026-07823-8","journal":{"identity":"bmc-oral-health","isVorOnly":false,"title":"BMC Oral Health"},"publishedOn":"2026-02-26 15:57:39","publishedOnDateReadable":"February 26th, 2026"},"versionCreatedAt":"2025-11-05 06:29:08","video":"","vorDoi":"10.1186/s12903-026-07823-8","vorDoiUrl":"https://doi.org/10.1186/s12903-026-07823-8","workflowStages":[]},"version":"v1","identity":"rs-7786121","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7786121","identity":"rs-7786121","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}