Biosilicate and Fluoride Treatments in Molar Incisor Hypomineralization: a randomized trial

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Abstract Objectives: To evaluate the effectiveness of a 10% Biosilicate® suspension compared with fluoride varnish in reducing dentin hypersensitivity in molar–incisor hypomineralization (MIH)-affected teeth in children. Materials and Methods: This randomized, parallel-arm clinical trial included 42 children aged 6–12 years presenting at least one erupted first permanent molar affected by MIH and dentin hypersensitivity (SCASS ≥2). Participants were randomly allocated to fluoride varnish or 10% Biosilicate® groups using a concealed allocation sequence. One eligible tooth per child was included in the analysis. The assigned material was applied once weekly for four consecutive weeks. Hypersensitivity was assessed using the Schiff Cold Air Sensitivity Scale (SCASS) and the Visual Analogue Scale (VAS) at baseline, before each weekly application, and at 1, 2, 4, and 8 weeks after treatment completion. Results: Forty-two children were randomized (22 in the fluoride varnish group and 20 in the Biosilicate® group completed the study). Both interventions significantly reduced hypersensitivity over time. However, Biosilicate® showed significantly greater reductions than fluoride varnish in VAS scores at 1, 2, 4, and 8 weeks, and in SCASS scores at 2, 4, and 8 weeks. Conclusions: Both treatments reduced dentin hypersensitivity in MIH-affected teeth. Biosilicate® showed a greater and more sustained desensitizing effect than fluoride varnish over the follow-up period. Clinical Relevance: Biosilicate® may represent an alternative desensitizing option for children with MIH-related dentin hypersensitivity, particularly when sustained symptom reduction is desired. Trial registration: ClinicalTrials.gov, NCT07080645, registered on 2025-07-30.
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Materials and Methods: This randomized, parallel-arm clinical trial included 42 children aged 6–12 years presenting at least one erupted first permanent molar affected by MIH and dentin hypersensitivity (SCASS ≥2). Participants were randomly allocated to fluoride varnish or 10% Biosilicate® groups using a concealed allocation sequence. One eligible tooth per child was included in the analysis. The assigned material was applied once weekly for four consecutive weeks. Hypersensitivity was assessed using the Schiff Cold Air Sensitivity Scale (SCASS) and the Visual Analogue Scale (VAS) at baseline, before each weekly application, and at 1, 2, 4, and 8 weeks after treatment completion. Results: Forty-two children were randomized (22 in the fluoride varnish group and 20 in the Biosilicate® group completed the study). Both interventions significantly reduced hypersensitivity over time. However, Biosilicate® showed significantly greater reductions than fluoride varnish in VAS scores at 1, 2, 4, and 8 weeks, and in SCASS scores at 2, 4, and 8 weeks. Conclusions: Both treatments reduced dentin hypersensitivity in MIH-affected teeth. Biosilicate® showed a greater and more sustained desensitizing effect than fluoride varnish over the follow-up period. Clinical Relevance: Biosilicate® may represent an alternative desensitizing option for children with MIH-related dentin hypersensitivity, particularly when sustained symptom reduction is desired. Trial registration: ClinicalTrials.gov, NCT07080645, registered on 2025-07-30. Molar-Incisor Hypomineralization Biosilicate Dentin hypersensitivity Dental enamel Child Figures Figure 1 Figure 2 Introduction Molar–incisor hypomineralization (MIH) is a qualitative enamel defect of multifactorial origin that affects one to four permanent first molars and may also involve other teeth [ 1 , 2 ]. The defect arises during the late stages of amelogenesis, particularly enamel mineralization and maturation, resulting in increased enamel porosity and reduced translucency due to altered ameloblast function [ 3 ]. MIH is a highly prevalent condition worldwide, with a global prevalence between 13.5% and 15.5% in children aged 6–12 years, underscoring its clinical and public health importance [ 4 , 5 ]. MIH has a multifactorial etiology involving prenatal, perinatal, and postnatal factors, as well as metabolic, environmental, and genetic influences, reflecting complex gene–environment interactions. [ 6 – 12 ]. Clinically, MIH is associated with increased risk of post-eruptive enamel breakdown (PEB), atypical restorations, dentin hypersensitivity, and complex restorative needs [ 13 , 14 ]. Additionally, affected children may experience difficulty with anesthesia, masticatory alterations, anxiety, and impaired oral health–related quality of life [ 15 – 18 ]. The high porosity of hypomineralized enamel facilitates bacterial penetration and fluid movement within dentinal tubules, which may contribute to subclinical pulpal inflammation and heightened sensitivity, even during routine stimuli such as toothbrushing [ 14 , 19 ]. Managing dentin hypersensitivity in MIH-affected teeth remains challenging, as no consensus exists regarding the most effective treatment strategy [ 20 , 21 ]. Conventional approaches include topical fluoride products, calcium–phosphate formulations, desensitizing agents with neural action, and adjunctive therapies such as lasers, although their effects may be limited or transient in structurally compromised enamel [ 22 , 23 ]. In this context, other bioactive materials have emerged as promising alternatives due to their ability to promote remineralization and dentinal tubule occlusion. Biosilicate®, a bioactive glass-ceramic capable of inducing hydroxyapatite formation, has shown encouraging results in recent clinical studies for dentin hypersensitivity management [ 24 , 25 ]. Therefore, the present study aimed to evaluate and compare the desensitizing effectiveness of a 10% Biosilicate® suspension and fluoride varnish in children with MIH-associated dentin hypersensitivity. Materials and Methods Ethical considerations This study was approved by the Research Ethics Committee of the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP–USP) (CAAE 63035222.3.0000.5419). It was conducted in accordance with the CONSORT guidelines and registered at ClinicalTrials.gov (NCT07080645). Written informed consent was obtained from legal guardians, and child assent was obtained following age-appropriate explanations. Sample size calculation Sample size calculation was based on the primary sensitivity outcome [ 14 ]. The calculation considered a minimum clinically relevant difference of 1.1 units between groups, a significance level of 5%, and 80% power. Based on these assumptions, the minimum required sample size was estimated at 17 participants per group. To compensate for possible attrition, 20% was added, resulting in a target sample of 21 participants per group. Patient selection According to the sample size calculation, at least 42 children (21 per group) presenting teeth affected by MIH and associated dentin hypersensitivity should be selected. Participants were recruited from public elementary schools in Ribeirão Preto (E.E. Edgardo Cajado and E.E. Fábio Barreto), São Paulo, Brazil, as well as from children receiving care at the Pediatric Dentistry Clinic and the Dental Enamel Clinic of the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP–USP), and MIH diagnosis was established according Ghanim et al. [ 26 ] criteria. Only children with at least one erupted first permanent molar affected by MIH were considered eligible. The examiner responsible for participant screening and MIH diagnosis underwent theoretical training and two calibration sessions using reference images. The reported kappa value (≥ 0.85) referred to intra-examiner agreement for MIH diagnosis. Inclusion criteria Children of both sexes aged 6 to 13 years, with at least one erupted first permanent molar affected by MIH; Presence of at least one permanent first molar affected by MIH, characterized by demarcated white or cream opacity (score 21), yellow or brown opacity (score 22), and/or (PEB) (score 3), associated with stimulus-induced dentin hypersensitivity, with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale (SCASS) [ 27 ]; Absence of systemic and/or cognitive impairment. Exclusion criteria Previous use of desensitizing therapy within the last 6 months; Use of analgesic or anti-inflammatory medication within the 3 days preceding the baseline assessment; Presence of orthodontic appliances; Teeth with extensive restorative procedures (e.g. stainless steel crowns); Diagnosis of amelogenesis imperfecta or dentinogenesis imperfecta; MIH teeth without hypersensitivity; Participants who missed more than one follow-up visit or who chose to withdraw from the study were considered losses to follow-up. For eligibility determination, the oral cavity was initially examined by a calibrated pediatric dentist at the Dental Enamel Clinic of the Department of Pediatric Dentistry, FORP–USP. Group allocation and interventions Participants were randomly allocated to one of two treatment groups: fluoride varnish (GI; Duraphat®, Colgate, Brazil) or 10% Biosilicate® suspension (GII). The random allocation sequence was generated prior to participant enrollment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after participant inclusion and immediately before treatment application. Duraphat® fluoride varnish (22,600 ppm fluoride) and the 10% Biosilicate® suspension (particle size < 1 µm) were both transferred to identical 10-mL plastic bottles to ensure participant blinding. The fluoride varnish was applied to the affected tooth surface using a microbrush for 15 seconds, followed by gentle water dripping. The Biosilicate® suspension was prepared immediately before application by mixing 0.15 mg of Biosilicate® powder with 1.35 mL of distilled water and was applied with a microbrush to all affected surfaces for 15 seconds. Children eligible for inclusion were referred for clinical examination at a mobile dental unit (Dental Case). Those presenting at least one permanent first molar affected by MIH, with complaints of dentin hypersensitivity and with or without PEB, were invited to participate. Hypersensitivity was confirmed by applying an air jet for 1 second at a distance of 1 cm from the occlusal surface of the affected tooth. A score of 2 or 3 on the SCASS was considered indicative of hypersensitivity [ 27 ]. Baseline comparability between groups was assessed after randomization. The tooth was considered the unit of analysis. In children presenting more than one tooth affected by MIH, only one type of treatment was applied to all eligible teeth to avoid potential confounding effects related to salivary flow. The order of teeth to be treated was determined by random draw. Blinding To ensure the first level of blinding, participants were unaware of their group allocation and of the type of treatment applied to the affected tooth. For this purpose, the tested materials were removed from their original packaging and transferred to identical white 10-mL bottles. The second level of blinding concerned the outcome assessment. All treatments were performed by a single operator, while sensitivity tests were conducted by a different examiner. In this way, the examiner responsible for outcome assessment was blinded to group allocation and to the type of intervention performed. To further increase the reliability of the results, the statistician was also blinded to group allocation and treatment identity. The statistical analysis was performed using a dataset in which groups were coded as A and B, containing only the test values, without disclosure of the corresponding interventions. Treatment protocols Children were treated in a mobile dental unit under standardized conditions. Dentin hypersensitivity was assessed using an air stimulus applied for 1 second at a distance of 1 cm from the occlusal surface, with adjacent teeth protected by cotton rolls. Sensitivity was evaluated using the SCASS, and pain intensity was recorded using the Visual Analog Scale (VAS; 0–10) [ 27 , 28 ]. Assessments were performed at baseline and at 1, 2, 4, and 8 weeks after completion of the treatment protocols. After relative isolation with cotton rolls and gentle drying of the affected tooth, the assigned material was actively applied with a microbrush to all affected surfaces for 15 seconds. In the GI, the fluoride varnish remained on the tooth surface after application. In the GII, the freshly prepared 10% Biosilicate® suspension was applied under the same conditions. After the procedure, children were instructed not to eat or drink for 40 minutes. Harms were predefined as any adverse local or systemic reactions associated with the interventions, including pain exacerbation, soft tissue irritation, or discomfort. Adverse events were systematically assessed at each follow-up visit through clinical examination and participant report. The study protocol would be discontinued under only two circumstances: (I) if no reduction in VAS scores was observed within 30 days. In such cases, the participant would be withdrawn from the study sample, and alternative treatment options would be provided to achieve pain relief; and (II) if participants chose to withdraw from the study at any time. Statistical analysis Statistical analyses were performed using JAMOVI software (version 2.4.5; Sydney, Australia). The significance level was set at 5% (α = 0.05). Because one tooth per child was included, the tooth-level outcome corresponded to one observation per participant. Descriptive analyses included medians, interquartile ranges, and minimum and maximum values. Longitudinal intragroup comparisons across repeated evaluations were performed using the Friedman test. When the overall test was significant, pairwise comparisons were conducted using the Durbin–Conover post hoc procedure. Intergroup comparisons at each time point were performed using the Mann–Whitney U test, and rank-biserial correlation ( r rb ) was calculated as effect size. Reduction in hypersensitivity was defined as the difference between baseline and follow-up scores for each outcome (VAS and SCASS). Correlations between outcomes were assessed using Spearman’s rank correlation coefficient. Results A total of 44 children were randomized, with 22 allocated to each group. Two children from the GII discontinued participation, resulting in a final sample of 22 children in the GI and 20 in the GII. Participant flow throughout the study is shown in Fig. 1 . No harms or adverse events were observed in either treatment group. Regarding the evaluated teeth, 25 (59.5%) were maxillary permanent first molars (teeth 16 or 26), and 17 (40.5%) were mandibular permanent first molars (teeth 36 or 46). Intragroup comparisons Table 1 presents the descriptive and inferential analyses of the VAS and the SCASS at baseline (before intervention) and at the follow-up periods of 1, 2, 4, and 8 weeks after treatment. The median values of both experimental groups across the evaluation periods are illustrated in Fig. 2 A (VAS) and Fig. 2 B (SCASS). In the GI, VAS scores were significantly lower at all follow-up periods compared with baseline (p < 0.001 for all comparisons). Among the post-intervention periods, VAS scores at 1 week were significantly higher than those observed at 2 weeks (p = 0.032) and 8 weeks (p = 0.008). No statistically significant differences were observed among the remaining post-intervention periods. For SCASS, scores were also significantly lower at all follow-up periods compared with baseline (p < 0.001 for all comparisons), with no statistically significant differences observed among the post-intervention periods. In the GII, VAS scores were significantly lower at all follow-up periods compared with baseline (p < 0.001 for all comparisons). Among the post-intervention periods, VAS scores at 1 and 2 weeks were significantly higher than those observed at 4 and 8 weeks (p < 0.001 for all comparisons). No statistically significant differences were observed among the remaining periods. Regarding SCASS scores, significant reductions were also observed at all follow-up periods compared with baseline (p < 0.001 for all comparisons). Among the post-intervention periods, SCASS scores at 1 week were significantly higher than those observed at 4 weeks (p = 0.010) and 8 weeks (p = 0.002). No statistically significant differences were observed among the remaining periods. Table 1 Descriptive and inferential analysis of dentin hypersensitivity assessed by the VAS and the SCASS at baseline and during follow-up periods. Groups Period Baseline 1 week 2 weeks 4 weeks 8 weeks GI VAS Median 6 A 4 B 3 C 4 BC 3 C IQR 4 2 2 3 3 Min 3 1 0 0 0 Max 10 9 9 9 8 SCASS Median 2 A 1 B 1 B 1 B 1 B IQR 1 0 0 0 0 Min 1 1 1 1 0 Max 3 2 2 2 2 GII VAS Median 6.5 A 1,5 B 1 B 0 C 0 C IQR 2 2 2 1 1 Min 3 0 0 0 0 Max 10 8 8 7 6 SCASS Median 2 A 1 B 0.5 BC 0 C 0 C IQR 1 1 1 1 1 Min 1 0 0 0 0 Max 3 2 2 2 2 GI: fluoride varnish group; GII: biosilicate group. VAS: Visual Analogue Scale; SCASS: Schiff Cold Air Sensitivity Scale. IQR: Interquartile range. Min: Minimum. Max: Maximum. Different superscript letters indicate statistically significant differences. Intergroup comparisons Table 2 presents the inferential analysis of the mean differences between the experimental groups at each evaluation period. For VAS scores, a significantly greater reduction from baseline was observed in the biosilicate group compared with the fluoride varnish group at 1 week (p = 0.011), 2 weeks (p = 0.022), 4 weeks (p < 0.001), and 8 weeks (p < 0.001). The magnitude of the effect was small at 1 and 2 weeks (rrb = 0.445 and 0.409, respectively) and moderate at 4 and 8 weeks (rrb = 0.668 and 0.686, respectively). For SCASS scores, a significantly greater reduction from baseline was observed in the biosilicate group at 2 weeks (p = 0.007), 4 weeks (p = 0.002), and 8 weeks (p = 0.001). No statistically significant intergroup difference was observed at 1 week (p = 0.113). The magnitude of the effect was small at 2 weeks (rrb = 0.445) and moderate at 4 and 8 weeks (rrb = 0.525 and 0.546, respectively). The mean intergroup differences for VAS and SCASS scores across the evaluation periods are illustrated in Fig. 2 C and Fig. 2 D, respectively. Table 2 Intergroup comparison of score reduction from baseline (difference) in dentin hypersensitivity scores between baseline and follow-up periods. Difference Period 1 week 2 weeks 4 weeks 8 weeks VAS GI -2.36 -3.01 -2.68 -2.98 GII -4.35 -4.70 -5.40 -5.60 p value 0.011* 0.022* < 0.001* < 0.001* rrb 0.445 0.409 0.668 0.686 SCASS GI -0.59 -0.54 -0.50 -0.59 GII -1.05 -1.20 -1.31 -1.35 p value 0.113 0.007* 0.002* 0.001* rrb 0.268 0.445 0.525 0.546 GI: Fluoride varnish group; GII: Biosilicate group. VAS: Visual Analogue Scale; SCASS: Schiff Cold Air Sensitivity Scale. rrb: rank-biserial correlation coefficient (effect size). *: p value statistically significant difference ( p < 0.05 ). Discussion The present study evaluated the clinical performance of Duraphat® (GI) and Biosilicate® (GII) as desensitizing agents in permanent teeth affected by MIH. The results demonstrated that both interventions were effective in reducing dentin hypersensitivity, as evidenced by significant reductions in VAS and SCASS scores throughout the eight-week follow-up period after completion of the treatment protocols. However, distinct response patterns were observed between the experimental groups, with GI showing an early reduction in sensitivity followed by stabilization, whereas GII exhibited a progressive and sustained decrease over time, suggesting a more persistent therapeutic effect. These differences can be explained by the underlying mechanisms of action of fluoride varnish. Fluoride-based agents act primarily through the formation of calcium fluoride–like deposits on the tooth surface, which partially occlude dentinal tubules and reduce fluid movement [ 29 ]. This effect, however, is largely superficial and susceptible to degradation by acidic challenges and mechanical forces such as toothbrushing [ 30 ]. As a result, repeated applications are often required to maintain desensitization, particularly in substrates with compromised structural integrity [ 31 , 32 ]. In the context of MIH, this limitation becomes especially relevant, as hypomineralized enamel presents increased porosity, reduced mineral density, and altered prism structure, factors that may impair the retention and durability of surface-applied agents [ 1 , 14 , 21 , 33 ]. Accordingly, MIH-specific evidence indicates that fluoride varnish remains one of the most frequently investigated agents. Muniz et al. [ 22 ] reported that Duraphat® was capable of reducing sensitivity in MIH-affected teeth, although its effect was delayed when compared with low-level laser therapy. Similarly, Olgen et al. [ 33 ] observed that fluoride varnish promoted some degree of remineralization, but its effectiveness was reduced in teeth presenting more severe enamel defects. Consistent with these findings, previous studies have demonstrated that fluoride varnish produces variable and often transient reductions in dentin hypersensitivity, even in structurally sound teeth [ 34 , 35 ]. Together, this body of evidence reinforces the notion that although fluoride varnish can provide clinical benefit, its efficacy may be limited in the presence of pronounced structural alterations such as those observed in MIH. In contrast, the superior intergroup performance observed for GII can be attributed to the bioactive properties of Biosilicate®, which enable chemical interaction with the dental substrate, ion release, and deep mineral deposition, leading to the formation of a stable mineralized layer within dentinal tubules [ 24 , 36 , 37 ]. In MIH-affected teeth, where increased enamel porosity may facilitate stimulus transmission toward the pulp, this deep mineralization mechanism plays a critical role in reducing pulpal irritation and hypersensitivity [ 36 , 37 ]. Accordingly, the greater and more sustained reductions in VAS and SCASS scores observed in GII are consistent with this mechanism, as Biosilicate® acts beyond the superficial enamel layer and promotes more durable structural changes, an effect also supported by previous clinical studies in non-cavitated root exposure [ 38 , 39 ]. Within this context, the present study contributes to the literature by specifically addressing desensitization in MIH-affected permanent molars, demonstrating that although both GI and GII were effective, GII showed superior intergroup efficacy with greater and more consistent reductions in VAS and SCASS scores across multiple time points. This superior performance likely reflects the greater compatibility of Biosilicate® with porous, hypomineralized substrates, promoting more effective tubule obliteration and longer-lasting clinical effects [ 22 , 33 – 35 , 38 ], supporting a more individualized approach to desensitizing therapy in MIH management. The interpretation of these findings should consider certain limitations. The inclusion of a single tooth per participant minimized clustering effects but may have limited generalizability, particularly for patients with multiple MIH-affected teeth. Although the eight-week follow-up was sufficient to assess short-term outcomes, it does not permit conclusions regarding long-term durability. Moreover, external factors that may influence treatment persistence were not controlled, and the absence of physicochemical or morphological analyses precludes direct confirmation of the mechanisms underlying desensitization. Despite these limitations, the present findings support the clinical effectiveness of bioactive materials, such as Biosilicate®, in reducing dentin hypersensitivity in MIH-affected teeth. Future multicenter studies incorporating longer follow-up periods, multiple affected teeth per patient, and stratification by lesion severity are warranted to confirm treatment durability and to further elucidate the biological mechanisms involved, thereby strengthening the evidence base for clinical management of MIH-related hypersensitivity. Conclusion Duraphat® and a 10% Biosilicate® suspension reduced dentin hypersensitivity in permanent teeth affected by MIH in children. Compared with fluoride varnish, Biosilicate® was associated with a greater and more sustained reduction in hypersensitivity over the evaluation period, supporting its use as an alternative desensitizing option for MIH-related dentin hypersensitivity. Declarations Funding The authors thank the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001, for financing the PhD students. Competing interests The authors declare no competing interests. Ethics approval This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Research Ethics Committee of the School of Dentistry of Ribeirão Preto, University of São Paulo (FORP-USP) (CAAE 63035222.3.0000.5419). Consent to participate Written informed consent was obtained from legal guardians, and assent was obtained from all children prior to participation. Consent to publish Not applicable. Data availability The data supporting the findings of this study are available in the Figshare repository at: https://doi.org/10.6084/m9.figshare.31158262 Acknowledgments None Author contributions section Paulla Iáddia Zarpellon Barbosa: Contributed to the acquisition, analysis, and drafted the manuscript; Lucas Masaru Marubayashi: Contributed to the acquisition, analysis, and drafted the manuscript; Oscar Peitl-Filho: Contributed to conceptualization and drafted the manuscript; Kelly Fernanda Molena: Contributed to the analysis and critically revised the manuscript; Fabrício Kitazono de Carvalho: Contributed to conceptualization, analysis, interpretation, and drafted the manuscript; Francisco Wanderley Garcia de Paula-Silva: Contributed to conceptualization, analysis, and drafted the manuscript; Fernanda de Carvalho Panzeri: Contributed to analysis, interpretation, and drafted the manuscript; Alexandra Mussolino de Queiroz: Contributed to conceptualization, analysis, interpretation, and critically revised the manuscript. 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Saudi J Health Sci. 14(2):109–119. doi:10.4103/sjhs.sjhs_25_25 Hjertberg E, Hajdarević A, Jälevik B (2025) Desensitization treatment in MIH-affected teeth: a systematic review. Eur Arch Paediatr Dent. 26(1):17-29. doi:10.1007/s40368-024-00934-2 Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC (2020) Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 30(3):323-333. doi: 10.1111/ipd.12602. Ishikiriama SK, Moreira BN, Wang L, Bombonatti JFS, Zabeu GS, Rizzante FAP (2025) Clinical evaluation of the effect of 980 nm diode laser and fluoride varnish on dentin hypersensitivity. Braz Oral Res. 39:e077. doi: 10.1590/1807-3107bor-2025.vol39.077. Roriz VM, Santana M, Boaventura VL, Zanotto ED, Peitl Filho O, Dias DR (2024) Efficacy of Biosilicate Glass-ceramic and Fluoride Varnish in the Treatment of Dentin Hypersensitivity-A Randomized Controlled Clinical Trial. Oper Dent. 49(3):253-261. doi: 10.2341/23-077-C. Dalmolin AC, Silva KR, Dechandt ICJ, Ribeiro KC, Gallo LS, Pochapski MT, Serbena FC, Dos Santos FA (2025) Efficiency of cavitary varnishes containing experimental bioglass particles in the occlusion of dentinal tubules. Odontology. 113(1):143-155. doi: 10.1007/s10266-024-00952-y. Ghanim A, Elfrink M, Weerheijm K, Mariño R, Manton D (2015) A practical method for use in epidemiological studies on enamel hypomineralisation. Eur Arch Paediatr Dent. 16(3):235-246. doi:10.1007/s40368-015-0178-8 Schiff T, Delgado E, Zhang YP, Cummins D, DeVizio W, Mateo LR (2009) Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity. Am J Dent. 22 Spec No A:8A-15A. Luyk NH, Beck FM, Weaver JM (1988) A visual analogue scale in the assessment of dental anxiety. Anesth Prog. 35(3):121-3. Baik A, Alamoudi N, El-Housseiny A, Altuwirqi A (2021) Fluoride Varnishes for Preventing Occlusal Dental Caries: A Review. Dent J (Basel). 9(6):64. doi:10.3390/dj9060064 Bezerra SJC, de Figueiredo RM, Kairalla CA, Aoki IV, Hara AT, Scaramucci T (2026) Synergistic effect of sodium fluoride and encapsulated calcium lactate on dental erosion-abrasion prevention. J Dent. 166:106503. doi: 10.1016/j.jdent.2026.106503. Magalhães AC, Kato MT, Rios D, Wiegand A, Attin T, Buzalaf MA (2008) The effect of an experimental 4% Tif4 varnish compared to NaF varnishes and 4% TiF4 solution on dental erosion in vitro. Caries Res. 42(4):269-74. doi: 10.1159/000135672. Jettanacheawchankit S, Pongpradit T, Euapokai A, Eiamsakul A, Wongmoon K, Wayakanon K (2025) Evaluating the effects of remineralizing agents on initial carious lesions. Can J Dent Hyg. 59(1):18-28. Olgen IC, Sonmez H, Bezgin T (2022) Effects of different remineralization agents on MIH defects: a randomized clinical study. Clin Oral Investig. 26(3):3227-3238. doi: 10.1007/s00784-021-04305-9. Camilotti V, Zilly J, Busato Pdo M, Nassar CA, Nassar PO (2012) Desensitizing treatments for dentin hypersensitivity: a randomized, split-mouth clinical trial. Braz Oral Res. 26(3):263-8. doi: 10.1590/s1806-83242012000300013. Abd El-Fattah Mohamed H, Ezzeldin Mohamed D, Hassanein E, Salah El-Din Hamza HE (2025) In vivo and in situ evaluation of innovative approaches in dentin hypersensitivity treatment. BMC Oral Health. 25(1):593. doi: 10.1186/s12903-025-05865-y. Tirapelli C, Panzeri H, Soares RG, Peitl O, Zanotto ED (2010) A novel bioactive glass-ceramic for treating dentin hypersensitivity. Braz Oral Res. 24(4):381-7. doi: 10.1590/s1806-83242010000400002. Silveira RE, Vivanco RG, de Morais RC, Da Col Dos Santos Pinto G, Pires-de-Souza FCP (2019) Bioactive glass ceramic can improve the bond strength of sealant/enamel? Eur Arch Paediatr Dent. 20(4):325-331. doi: 10.1007/s40368-018-0409-x. Ramos FSES, Briso ALF, Albertinazzi L, Marchetti VM, Souza MT, Fagundes TC (2024) Efficacy of different in-office treatments for dentin hypersensitivity: randomized and parallel clinical trial. Braz Dent J. 35:e245487. doi:10.1590/0103-6440202405487 Roriz VM, Santana M, Boaventura VL, Zanotto ED, Peitl Filho O, Dias DR (2024) Efficacy of Biosilicate Glass-ceramic and Fluoride Varnish in the Treatment of Dentin Hypersensitivity-A Randomized Controlled Clinical Trial. Oper Dent. 49(3):253-261. doi: 10.2341/23-077-C. Additional Declarations No competing interests reported. Supplementary Files CONSORT2025checklistCOI.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 12 May, 2026 Reviewers agreed at journal 11 May, 2026 Reviewers agreed at journal 11 May, 2026 Reviews received at journal 07 May, 2026 Reviewers agreed at journal 07 May, 2026 Reviewers invited by journal 06 May, 2026 Editor assigned by journal 23 Mar, 2026 Submission checks completed at journal 23 Mar, 2026 First submitted to journal 20 Mar, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9180093","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":638722108,"identity":"8b1c9b28-19fd-4470-aa3b-8846d2adf2a1","order_by":0,"name":"Paulla Iáddia Zarpellon Barbosa","email":"","orcid":"","institution":"Universidade de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Paulla","middleName":"Iáddia Zarpellon","lastName":"Barbosa","suffix":""},{"id":638722110,"identity":"af6ec3b9-6101-4cdd-9331-2128fa251ae6","order_by":1,"name":"Lucas Masaru Marubayashi","email":"","orcid":"","institution":"University of São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Lucas","middleName":"Masaru","lastName":"Marubayashi","suffix":""},{"id":638722111,"identity":"7b4f8306-aacc-4773-9f47-3ed8cb03a9ec","order_by":2,"name":"Oscar Peitl-Filho","email":"","orcid":"","institution":"Federal University of São Carlos","correspondingAuthor":false,"prefix":"","firstName":"Oscar","middleName":"","lastName":"Peitl-Filho","suffix":""},{"id":638722113,"identity":"dd375c0d-0670-4056-a45e-19e6e4faf6b6","order_by":3,"name":"Kelly Fernanda Molena","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA10lEQVRIiWNgGAWjYBACCQbmxgMgBh+I+AARIqSFsQGshQ2IGWeQrIWZhxgtku2NDYd5GLbJsbH3Hvxs21aXxyDd+wCvFmmegyAtt43ZeM4lS+e2HS5mkDlugFeLnEQiWEtim0SOAVDLgcQGiTT8DpOTfwjVIv/G+LdlWx1hLdISjDBbeMykGduYCWuR7ElsODjHAOSXHDPLnnOHi9lkjuHXInH88MEHbypuy/GznzG+8aOsLo9fug2/FhBg4kEKogQ2whqAkf4DiZNAjI5RMApGwSgYWQAA52hB+4o05WkAAAAASUVORK5CYII=","orcid":"","institution":"University of São Paulo","correspondingAuthor":true,"prefix":"","firstName":"Kelly","middleName":"Fernanda","lastName":"Molena","suffix":""},{"id":638722115,"identity":"a3e0d1b4-0073-47af-9ff1-737f681e6fff","order_by":4,"name":"Fabrício Kitazono de Carvalho","email":"","orcid":"","institution":"University of São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Fabrício","middleName":"Kitazono","lastName":"de Carvalho","suffix":""},{"id":638722116,"identity":"24a69b5f-a932-4cd2-87a1-35ef8eb434b6","order_by":5,"name":"Francisco Wanderley Garcia de Paula-Silva","email":"","orcid":"","institution":"Universidade de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Francisco","middleName":"Wanderley Garcia","lastName":"de Paula-Silva","suffix":""},{"id":638722118,"identity":"4ed72255-449f-48aa-99c5-fd654bbb90f7","order_by":6,"name":"Fernanda de Carvalho Panzeri","email":"","orcid":"","institution":"University of São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Fernanda","middleName":"de Carvalho","lastName":"Panzeri","suffix":""},{"id":638722119,"identity":"33554be0-9f4d-4553-98c9-8afc9443b421","order_by":7,"name":"Alexandra Mussolino de Queiroz","email":"","orcid":"","institution":"Universidade de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Alexandra","middleName":"Mussolino","lastName":"de Queiroz","suffix":""}],"badges":[],"createdAt":"2026-03-20 14:55:17","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9180093/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9180093/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":109303686,"identity":"8dd1c43a-43cb-48b2-bf62-1a5e22f96ec5","added_by":"auto","created_at":"2026-05-15 09:40:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":149686,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram of participants throughout the randomized clinical trial. GI: Fluoride varnish group; GII: Biosilicate group.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-9180093/v1/af80c126fe1e82bc00d6ae3a.png"},{"id":109303872,"identity":"04d2c7f5-bdfa-4ecf-a457-67f0100c6248","added_by":"auto","created_at":"2026-05-15 09:40:59","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":159382,"visible":true,"origin":"","legend":"\u003cp\u003eMedian values and score reductions from baseline for dentin hypersensitivity outcomes over time. (A) VAS median scores at baseline, 1, 2, 4, and 8 weeks. (B) SCASS median scores at the same evaluation periods. (C) Mean differences in VAS scores between baseline and follow-up periods for each group. (D) Mean differences in SCASS scores between baseline and follow-up periods for each group. GI: Fluoride varnish group; GII: Biosilicate group. VAS: Visual Analogue Scale; SCASS: Schiff Cold Air Sensitivity Scale.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-9180093/v1/459a3201bb2420be4a14fdf5.png"},{"id":109405551,"identity":"4472c1fb-a578-47ec-bc03-c2a307e59b4c","added_by":"auto","created_at":"2026-05-17 13:18:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":517262,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9180093/v1/e574a530-3d63-4bf9-8460-8dcefae77b52.pdf"},{"id":109303885,"identity":"58c3f9bf-e9bb-4ab6-8464-ea0d5eb863d9","added_by":"auto","created_at":"2026-05-15 09:41:00","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":52851,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORT2025checklistCOI.docx","url":"https://assets-eu.researchsquare.com/files/rs-9180093/v1/4d88147e99668b7887797629.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Biosilicate and Fluoride Treatments in Molar Incisor Hypomineralization: a randomized trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMolar\u0026ndash;incisor hypomineralization (MIH) is a qualitative enamel defect of multifactorial origin that affects one to four permanent first molars and may also involve other teeth [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The defect arises during the late stages of amelogenesis, particularly enamel mineralization and maturation, resulting in increased enamel porosity and reduced translucency due to altered ameloblast function [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. MIH is a highly prevalent condition worldwide, with a global prevalence between 13.5% and 15.5% in children aged 6\u0026ndash;12 years, underscoring its clinical and public health importance [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. MIH has a multifactorial etiology involving prenatal, perinatal, and postnatal factors, as well as metabolic, environmental, and genetic influences, reflecting complex gene\u0026ndash;environment interactions. [\u003cspan additionalcitationids=\"CR7 CR8 CR9 CR10 CR11\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eClinically, MIH is associated with increased risk of post-eruptive enamel breakdown (PEB), atypical restorations, dentin hypersensitivity, and complex restorative needs [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Additionally, affected children may experience difficulty with anesthesia, masticatory alterations, anxiety, and impaired oral health\u0026ndash;related quality of life [\u003cspan additionalcitationids=\"CR16 CR17\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The high porosity of hypomineralized enamel facilitates bacterial penetration and fluid movement within dentinal tubules, which may contribute to subclinical pulpal inflammation and heightened sensitivity, even during routine stimuli such as toothbrushing [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eManaging dentin hypersensitivity in MIH-affected teeth remains challenging, as no consensus exists regarding the most effective treatment strategy [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Conventional approaches include topical fluoride products, calcium\u0026ndash;phosphate formulations, desensitizing agents with neural action, and adjunctive therapies such as lasers, although their effects may be limited or transient in structurally compromised enamel [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. In this context, other bioactive materials have emerged as promising alternatives due to their ability to promote remineralization and dentinal tubule occlusion. Biosilicate\u0026reg;, a bioactive glass-ceramic capable of inducing hydroxyapatite formation, has shown encouraging results in recent clinical studies for dentin hypersensitivity management [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Therefore, the present study aimed to evaluate and compare the desensitizing effectiveness of a 10% Biosilicate\u0026reg; suspension and fluoride varnish in children with MIH-associated dentin hypersensitivity.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eEthical considerations\u003c/h2\u003e \u003cp\u003e This study was approved by the Research Ethics Committee of the School of Dentistry of Ribeir\u0026atilde;o Preto, University of S\u0026atilde;o Paulo (FORP\u0026ndash;USP) (CAAE 63035222.3.0000.5419). It was conducted in accordance with the CONSORT guidelines and registered at ClinicalTrials.gov (NCT07080645). Written informed consent was obtained from legal guardians, and child assent was obtained following age-appropriate explanations.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSample size calculation\u003c/h3\u003e\n\u003cp\u003eSample size calculation was based on the primary sensitivity outcome [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The calculation considered a minimum clinically relevant difference of 1.1 units between groups, a significance level of 5%, and 80% power. Based on these assumptions, the minimum required sample size was estimated at 17 participants per group. To compensate for possible attrition, 20% was added, resulting in a target sample of 21 participants per group.\u003c/p\u003e\n\u003ch3\u003ePatient selection\u003c/h3\u003e\n\u003cp\u003eAccording to the sample size calculation, at least 42 children (21 per group) presenting teeth affected by MIH and associated dentin hypersensitivity should be selected. Participants were recruited from public elementary schools in Ribeir\u0026atilde;o Preto (E.E. Edgardo Cajado and E.E. F\u0026aacute;bio Barreto), S\u0026atilde;o Paulo, Brazil, as well as from children receiving care at the Pediatric Dentistry Clinic and the Dental Enamel Clinic of the School of Dentistry of Ribeir\u0026atilde;o Preto, University of S\u0026atilde;o Paulo (FORP\u0026ndash;USP), and MIH diagnosis was established according Ghanim et al. [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] criteria. Only children with at least one erupted first permanent molar affected by MIH were considered eligible. The examiner responsible for participant screening and MIH diagnosis underwent theoretical training and two calibration sessions using reference images. The reported kappa value (\u0026ge;\u0026thinsp;0.85) referred to intra-examiner agreement for MIH diagnosis.\u003c/p\u003e\n\u003ch3\u003eInclusion criteria\u003c/h3\u003e\n\u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eChildren of both sexes aged 6 to 13 years, with at least one erupted first permanent molar affected by MIH;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePresence of at least one permanent first molar affected by MIH, characterized by demarcated white or cream opacity (score 21), yellow or brown opacity (score 22), and/or (PEB) (score 3), associated with stimulus-induced dentin hypersensitivity, with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale (SCASS) [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e];\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAbsence of systemic and/or cognitive impairment.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e\n\u003ch3\u003eExclusion criteria\u003c/h3\u003e\n\u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003ePrevious use of desensitizing therapy within the last 6 months;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUse of analgesic or anti-inflammatory medication within the 3 days preceding the baseline assessment;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePresence of orthodontic appliances;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTeeth with extensive restorative procedures (e.g. stainless steel crowns);\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDiagnosis of amelogenesis imperfecta or dentinogenesis imperfecta;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eMIH teeth without hypersensitivity;\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eParticipants who missed more than one follow-up visit or who chose to withdraw from the study were considered losses to follow-up. For eligibility determination, the oral cavity was initially examined by a calibrated pediatric dentist at the Dental Enamel Clinic of the Department of Pediatric Dentistry, FORP\u0026ndash;USP.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eGroup allocation and interventions\u003c/h2\u003e \u003cp\u003eParticipants were randomly allocated to one of two treatment groups: fluoride varnish (GI; Duraphat\u0026reg;, Colgate, Brazil) or 10% Biosilicate\u0026reg; suspension (GII). The random allocation sequence was generated prior to participant enrollment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after participant inclusion and immediately before treatment application.\u003c/p\u003e \u003cp\u003eDuraphat\u0026reg; fluoride varnish (22,600 ppm fluoride) and the 10% Biosilicate\u0026reg; suspension (particle size\u0026thinsp;\u0026lt;\u0026thinsp;1 \u0026micro;m) were both transferred to identical 10-mL plastic bottles to ensure participant blinding. The fluoride varnish was applied to the affected tooth surface using a microbrush for 15 seconds, followed by gentle water dripping. The Biosilicate\u0026reg; suspension was prepared immediately before application by mixing 0.15 mg of Biosilicate\u0026reg; powder with 1.35 mL of distilled water and was applied with a microbrush to all affected surfaces for 15 seconds.\u003c/p\u003e \u003cp\u003eChildren eligible for inclusion were referred for clinical examination at a mobile dental unit (Dental Case). Those presenting at least one permanent first molar affected by MIH, with complaints of dentin hypersensitivity and with or without PEB, were invited to participate. Hypersensitivity was confirmed by applying an air jet for 1 second at a distance of 1 cm from the occlusal surface of the affected tooth. A score of 2 or 3 on the SCASS was considered indicative of hypersensitivity [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Baseline comparability between groups was assessed after randomization.\u003c/p\u003e \u003cp\u003eThe tooth was considered the unit of analysis. In children presenting more than one tooth affected by MIH, only one type of treatment was applied to all eligible teeth to avoid potential confounding effects related to salivary flow. The order of teeth to be treated was determined by random draw.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eBlinding\u003c/h3\u003e\n\u003cp\u003eTo ensure the first level of blinding, participants were unaware of their group allocation and of the type of treatment applied to the affected tooth. For this purpose, the tested materials were removed from their original packaging and transferred to identical white 10-mL bottles.\u003c/p\u003e \u003cp\u003eThe second level of blinding concerned the outcome assessment. All treatments were performed by a single operator, while sensitivity tests were conducted by a different examiner. In this way, the examiner responsible for outcome assessment was blinded to group allocation and to the type of intervention performed.\u003c/p\u003e \u003cp\u003eTo further increase the reliability of the results, the statistician was also blinded to group allocation and treatment identity. The statistical analysis was performed using a dataset in which groups were coded as A and B, containing only the test values, without disclosure of the corresponding interventions.\u003c/p\u003e\n\u003ch3\u003eTreatment protocols\u003c/h3\u003e\n\u003cp\u003eChildren were treated in a mobile dental unit under standardized conditions. Dentin hypersensitivity was assessed using an air stimulus applied for 1 second at a distance of 1 cm from the occlusal surface, with adjacent teeth protected by cotton rolls. Sensitivity was evaluated using the SCASS, and pain intensity was recorded using the Visual Analog Scale (VAS; 0\u0026ndash;10) [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Assessments were performed at baseline and at 1, 2, 4, and 8 weeks after completion of the treatment protocols.\u003c/p\u003e \u003cp\u003eAfter relative isolation with cotton rolls and gentle drying of the affected tooth, the assigned material was actively applied with a microbrush to all affected surfaces for 15 seconds. In the GI, the fluoride varnish remained on the tooth surface after application. In the GII, the freshly prepared 10% Biosilicate\u0026reg; suspension was applied under the same conditions. After the procedure, children were instructed not to eat or drink for 40 minutes.\u003c/p\u003e \u003cp\u003eHarms were predefined as any adverse local or systemic reactions associated with the interventions, including pain exacerbation, soft tissue irritation, or discomfort. Adverse events were systematically assessed at each follow-up visit through clinical examination and participant report. The study protocol would be discontinued under only two circumstances: (I) if no reduction in VAS scores was observed within 30 days. In such cases, the participant would be withdrawn from the study sample, and alternative treatment options would be provided to achieve pain relief; and (II) if participants chose to withdraw from the study at any time.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eStatistical analyses were performed using JAMOVI software (version 2.4.5; Sydney, Australia). The significance level was set at 5% (α\u0026thinsp;=\u0026thinsp;0.05). Because one tooth per child was included, the tooth-level outcome corresponded to one observation per participant. Descriptive analyses included medians, interquartile ranges, and minimum and maximum values.\u003c/p\u003e \u003cp\u003eLongitudinal intragroup comparisons across repeated evaluations were performed using the Friedman test. When the overall test was significant, pairwise comparisons were conducted using the Durbin\u0026ndash;Conover post hoc procedure. Intergroup comparisons at each time point were performed using the Mann\u0026ndash;Whitney U test, and rank-biserial correlation (\u003cem\u003er\u003c/em\u003e\u003csub\u003erb\u003c/sub\u003e) was calculated as effect size. Reduction in hypersensitivity was defined as the difference between baseline and follow-up scores for each outcome (VAS and SCASS). Correlations between outcomes were assessed using Spearman\u0026rsquo;s rank correlation coefficient.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 44 children were randomized, with 22 allocated to each group. Two children from the GII discontinued participation, resulting in a final sample of 22 children in the GI and 20 in the GII. Participant flow throughout the study is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. No harms or adverse events were observed in either treatment group. Regarding the evaluated teeth, 25 (59.5%) were maxillary permanent first molars (teeth 16 or 26), and 17 (40.5%) were mandibular permanent first molars (teeth 36 or 46).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eIntragroup comparisons\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the descriptive and inferential analyses of the VAS and the SCASS at baseline (before intervention) and at the follow-up periods of 1, 2, 4, and 8 weeks after treatment. The median values of both experimental groups across the evaluation periods are illustrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA (VAS) and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB (SCASS).\u003c/p\u003e \u003cp\u003eIn the GI, VAS scores were significantly lower at all follow-up periods compared with baseline (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for all comparisons). Among the post-intervention periods, VAS scores at 1 week were significantly higher than those observed at 2 weeks (p\u0026thinsp;=\u0026thinsp;0.032) and 8 weeks (p\u0026thinsp;=\u0026thinsp;0.008). No statistically significant differences were observed among the remaining post-intervention periods. For SCASS, scores were also significantly lower at all follow-up periods compared with baseline (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for all comparisons), with no statistically significant differences observed among the post-intervention periods.\u003c/p\u003e \u003cp\u003eIn the GII, VAS scores were significantly lower at all follow-up periods compared with baseline (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for all comparisons). Among the post-intervention periods, VAS scores at 1 and 2 weeks were significantly higher than those observed at 4 and 8 weeks (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for all comparisons). No statistically significant differences were observed among the remaining periods. Regarding SCASS scores, significant reductions were also observed at all follow-up periods compared with baseline (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for all comparisons). Among the post-intervention periods, SCASS scores at 1 week were significantly higher than those observed at 4 weeks (p\u0026thinsp;=\u0026thinsp;0.010) and 8 weeks (p\u0026thinsp;=\u0026thinsp;0.002). No statistically significant differences were observed among the remaining periods.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDescriptive and inferential analysis of dentin hypersensitivity assessed by the VAS and the SCASS at baseline and during follow-up periods.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroups\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c7\" namest=\"c3\"\u003e \u003cp\u003ePeriod\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eBaseline\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003e1 week\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e2 weeks\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003e4 weeks\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003e8 weeks\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003e\u003cb\u003eGI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c7\" namest=\"c3\"\u003e \u003cp\u003e\u003cb\u003eVAS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003csup\u003eA\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003csup\u003eBC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c7\" namest=\"c3\"\u003e \u003cp\u003e\u003cb\u003eSCASS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003csup\u003eA\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003e\u003cb\u003eGII\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c7\" namest=\"c3\"\u003e \u003cp\u003e\u003cb\u003eVAS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.5\u003csup\u003eA\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1,5\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c7\" namest=\"c3\"\u003e \u003cp\u003e\u003cb\u003eSCASS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003csup\u003eA\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003csup\u003eB\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5\u003csup\u003eBC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIQR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eGI: fluoride varnish group; GII: biosilicate group. VAS: Visual Analogue Scale; SCASS: Schiff Cold Air Sensitivity Scale. IQR: Interquartile range. Min: Minimum. Max: Maximum. Different superscript letters indicate statistically significant differences.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eIntergroup comparisons\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e presents the inferential analysis of the mean differences between the experimental groups at each evaluation period. For VAS scores, a significantly greater reduction from baseline was observed in the biosilicate group compared with the fluoride varnish group at 1 week (p\u0026thinsp;=\u0026thinsp;0.011), 2 weeks (p\u0026thinsp;=\u0026thinsp;0.022), 4 weeks (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and 8 weeks (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The magnitude of the effect was small at 1 and 2 weeks (rrb\u0026thinsp;=\u0026thinsp;0.445 and 0.409, respectively) and moderate at 4 and 8 weeks (rrb\u0026thinsp;=\u0026thinsp;0.668 and 0.686, respectively).\u003c/p\u003e \u003cp\u003eFor SCASS scores, a significantly greater reduction from baseline was observed in the biosilicate group at 2 weeks (p\u0026thinsp;=\u0026thinsp;0.007), 4 weeks (p\u0026thinsp;=\u0026thinsp;0.002), and 8 weeks (p\u0026thinsp;=\u0026thinsp;0.001). No statistically significant intergroup difference was observed at 1 week (p\u0026thinsp;=\u0026thinsp;0.113). The magnitude of the effect was small at 2 weeks (rrb\u0026thinsp;=\u0026thinsp;0.445) and moderate at 4 and 8 weeks (rrb\u0026thinsp;=\u0026thinsp;0.525 and 0.546, respectively).\u003c/p\u003e \u003cp\u003eThe mean intergroup differences for VAS and SCASS scores across the evaluation periods are illustrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eC and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eD, respectively.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eIntergroup comparison of score reduction from baseline (difference) in dentin hypersensitivity scores between baseline and follow-up periods.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eDifference\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003ePeriod\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003e1 week\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003e2 weeks\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003e4 weeks\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003e8 weeks\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003e\u003cb\u003eVAS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-2.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-3.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-2.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-2.98\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGII\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-4.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-4.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-5.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-5.60\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ep value\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.011*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.022*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003errb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.445\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.409\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.668\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.686\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e \u003cp\u003e\u003cb\u003eSCASS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-0.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-0.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGII\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-1.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-1.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-1.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-1.35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ep value\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.113\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.007*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.002*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.001*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003errb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.268\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.445\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.525\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.546\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eGI: Fluoride varnish group; GII: Biosilicate group. VAS: Visual Analogue Scale; SCASS: Schiff Cold Air Sensitivity Scale. rrb: rank-biserial correlation coefficient (effect size). *: \u003cem\u003ep value\u003c/em\u003e statistically significant difference (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/em\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe present study evaluated the clinical performance of Duraphat\u0026reg; (GI) and Biosilicate\u0026reg; (GII) as desensitizing agents in permanent teeth affected by MIH. The results demonstrated that both interventions were effective in reducing dentin hypersensitivity, as evidenced by significant reductions in VAS and SCASS scores throughout the eight-week follow-up period after completion of the treatment protocols. However, distinct response patterns were observed between the experimental groups, with GI showing an early reduction in sensitivity followed by stabilization, whereas GII exhibited a progressive and sustained decrease over time, suggesting a more persistent therapeutic effect.\u003c/p\u003e \u003cp\u003eThese differences can be explained by the underlying mechanisms of action of fluoride varnish. Fluoride-based agents act primarily through the formation of calcium fluoride\u0026ndash;like deposits on the tooth surface, which partially occlude dentinal tubules and reduce fluid movement [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. This effect, however, is largely superficial and susceptible to degradation by acidic challenges and mechanical forces such as toothbrushing [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. As a result, repeated applications are often required to maintain desensitization, particularly in substrates with compromised structural integrity [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In the context of MIH, this limitation becomes especially relevant, as hypomineralized enamel presents increased porosity, reduced mineral density, and altered prism structure, factors that may impair the retention and durability of surface-applied agents [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAccordingly, MIH-specific evidence indicates that fluoride varnish remains one of the most frequently investigated agents. Muniz et al. [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] reported that Duraphat\u0026reg; was capable of reducing sensitivity in MIH-affected teeth, although its effect was delayed when compared with low-level laser therapy. Similarly, Olgen et al. [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] observed that fluoride varnish promoted some degree of remineralization, but its effectiveness was reduced in teeth presenting more severe enamel defects. Consistent with these findings, previous studies have demonstrated that fluoride varnish produces variable and often transient reductions in dentin hypersensitivity, even in structurally sound teeth [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. Together, this body of evidence reinforces the notion that although fluoride varnish can provide clinical benefit, its efficacy may be limited in the presence of pronounced structural alterations such as those observed in MIH.\u003c/p\u003e \u003cp\u003eIn contrast, the superior intergroup performance observed for GII can be attributed to the bioactive properties of Biosilicate\u0026reg;, which enable chemical interaction with the dental substrate, ion release, and deep mineral deposition, leading to the formation of a stable mineralized layer within dentinal tubules [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. In MIH-affected teeth, where increased enamel porosity may facilitate stimulus transmission toward the pulp, this deep mineralization mechanism plays a critical role in reducing pulpal irritation and hypersensitivity [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Accordingly, the greater and more sustained reductions in VAS and SCASS scores observed in GII are consistent with this mechanism, as Biosilicate\u0026reg; acts beyond the superficial enamel layer and promotes more durable structural changes, an effect also supported by previous clinical studies in non-cavitated root exposure [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWithin this context, the present study contributes to the literature by specifically addressing desensitization in MIH-affected permanent molars, demonstrating that although both GI and GII were effective, GII showed superior intergroup efficacy with greater and more consistent reductions in VAS and SCASS scores across multiple time points. This superior performance likely reflects the greater compatibility of Biosilicate\u0026reg; with porous, hypomineralized substrates, promoting more effective tubule obliteration and longer-lasting clinical effects [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan additionalcitationids=\"CR34\" citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e], supporting a more individualized approach to desensitizing therapy in MIH management.\u003c/p\u003e \u003cp\u003eThe interpretation of these findings should consider certain limitations. The inclusion of a single tooth per participant minimized clustering effects but may have limited generalizability, particularly for patients with multiple MIH-affected teeth. Although the eight-week follow-up was sufficient to assess short-term outcomes, it does not permit conclusions regarding long-term durability. Moreover, external factors that may influence treatment persistence were not controlled, and the absence of physicochemical or morphological analyses precludes direct confirmation of the mechanisms underlying desensitization.\u003c/p\u003e \u003cp\u003eDespite these limitations, the present findings support the clinical effectiveness of bioactive materials, such as Biosilicate\u0026reg;, in reducing dentin hypersensitivity in MIH-affected teeth. Future multicenter studies incorporating longer follow-up periods, multiple affected teeth per patient, and stratification by lesion severity are warranted to confirm treatment durability and to further elucidate the biological mechanisms involved, thereby strengthening the evidence base for clinical management of MIH-related hypersensitivity.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eDuraphat\u0026reg; and a 10% Biosilicate\u0026reg; suspension reduced dentin hypersensitivity in permanent teeth affected by MIH in children. Compared with fluoride varnish, Biosilicate\u0026reg; was associated with a greater and more sustained reduction in hypersensitivity over the evaluation period, supporting its use as an alternative desensitizing option for MIH-related dentin hypersensitivity.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the Coordena\u0026ccedil;\u0026atilde;o de Aperfei\u0026ccedil;oamento de Pessoal de N\u0026iacute;vel Superior \u0026ndash; Brasil (CAPES) \u0026ndash; Finance Code 001, for financing the PhD students.\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\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Research Ethics Committee of the School of Dentistry of Ribeir\u0026atilde;o Preto, University of S\u0026atilde;o Paulo (FORP-USP) (CAAE 63035222.3.0000.5419).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from legal guardians, and assent was obtained from all children prior to participation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to publish\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data supporting the findings of this study are available in the Figshare repository at: https://doi.org/10.6084/m9.figshare.31158262\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor contributions section\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePaulla I\u0026aacute;ddia Zarpellon Barbosa: Contributed to the acquisition, analysis, and drafted the manuscript;\u003c/p\u003e\n\u003cp\u003eLucas Masaru Marubayashi: Contributed to the acquisition, analysis, and drafted the manuscript;\u003c/p\u003e\n\u003cp\u003eOscar Peitl-Filho: Contributed to conceptualization and drafted the manuscript;\u003c/p\u003e\n\u003cp\u003eKelly Fernanda Molena: Contributed to the analysis and critically revised the manuscript;\u003c/p\u003e\n\u003cp\u003eFabr\u0026iacute;cio Kitazono de Carvalho: Contributed to conceptualization, analysis, interpretation, and drafted the manuscript;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFrancisco Wanderley Garcia de Paula-Silva: Contributed to conceptualization, analysis, and drafted the manuscript;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFernanda de Carvalho Panzeri: Contributed to analysis, interpretation, and drafted the manuscript;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlexandra Mussolino de Queiroz: Contributed to conceptualization, analysis, interpretation, and critically revised the manuscript.\u003c/p\u003e\n\u003cp\u003eAll authors gave their final approval and agree to be accountable for all aspects of the work.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eWeerheijm KL, J\u0026auml;levik B, Alaluusua S (2001) Molar-incisor hypomineralisation. Caries Res. 35(5):390-1. doi: 10.1159/000047479.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eKirthiga M, Poornima P, Praveen R, Gayathri P, Manju M, Priya M (2015) Prevalence and severity of molar incisor hypomineralization in children aged 11-16 years of a city in Karnataka, Davangere. J Indian Soc Pedod Prev Dent. 33(3):213-7. doi: 10.4103/0970-4388.160366.\u003c/li\u003e\n \u003cli\u003eSilva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N (2016) Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 44(4):342-53. doi: 10.1111/cdoe.12229.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSluka B, Held U, Wegehaupt F, Neuhaus KW, Attin T, Sahrmann P (2024) Is there a rise of prevalence for molar incisor hypomineralization? A meta‑analysis of published data. BMC Oral Health. 24(1):127. doi:10.1186/s12903‑023‑03637‑0.\u003c/li\u003e\n \u003cli\u003eAmmar N, Fresen KF, Schwendicke F, K\u0026uuml;hnisch J (2025) Epidemiological trends in enamel hypomineralisation and molar-incisor hypomineralisation: a systematic review and meta-analysis. Clin Oral Investig.29(6):327. doi: 10.1007/s00784-025-06411-4.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eJ\u0026auml;levik B, Nor\u0026eacute;n JG, Klingberg G, Barreg\u0026aring;rd L (2001) Etiologic factors influencing the prevalence of demarcated opacities in permanent first molars in a group of Swedish children. Eur J Oral Sci. 109(4):230-4. doi: 10.1034/j.1600-0722.2001.00047.x.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCrombie F, Manton D, Kilpatrick N (2009) Aetiology of molar-incisor hypomineralization: a critical review. Int J Paediatr Dent. 19(2):73-83. doi: 10.1111/j.1365-263X.2008.00966.x.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAlaluusua S (2010) Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 11(2):53-8. doi: 10.1007/BF03262713.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eVoll\u0026uacute; AL, Pintor AVB, Maran\u0026oacute;n-V\u0026aacute;squez GA, Magno MB, Maia LC, Fonseca-Gon\u0026ccedil;alves A (2024) Are low serum levels of Vitamin D associated with dental developmental defects in primary teeth? A systematic review. Evid Based Dent. 25(2):110. doi: 10.1038/s41432-023-00967-4.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePaulo AC, Molena KF, Moreira BM, Carvalho FK, Bezerra Segato RA, Paula-Silva FMG \u0026nbsp;(2025) The impact of antibiotic use on dental enamel development defects: a systematic review of studies in animal models. RSBO. 22(1):67-75. \u0026nbsp;doi:\u0026nbsp;10.21726/rsbo.v22i1.2663\u003c/li\u003e\n \u003cli\u003ePiekoszewska-Ziętek P, Spodzieja K, Olczak-Kowalczyk D (2025) Influence of Vitamin D on Developmental Defects of Enamel (DDE) in Children and Adolescents: A Systematic Review. Nutrients. 17(8):1317. doi: 10.3390/nu17081317..\u003c/li\u003e\n \u003cli\u003eLopes-Fatturi A, Fonseca-Souza G, Wambier LM, Brancher JA, K\u0026uuml;chler EC, Feltrin-Souza J (2025) Genetic polymorphisms associated with developmental defects of enamel: A systematic review. Int J Paediatr Dent. 35(2):298-310. doi: 10.1111/ipd.13233.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAllazzam SM, Alaki SM, El Meligy AO (2014) Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014:234508. doi: 10.1155/2014/234508.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBekes K, Steffen R, Kr\u0026auml;mer N (2023) Update of the molar incisor hypomineralization: W\u0026uuml;rzburg concept. Eur Arch Paediatr Dent. 24(6):807-813. doi: 10.1007/s40368-023-00848-5.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eVicioni-Marques F, Paula-Silva FWG, Carvalho MR, Queiroz AM, Freitas O, Duarte MPF, Manton DJ, Carvalho FK (2022) Preemptive analgesia with ibuprofen increases anesthetic efficacy in children with severe molar: a triple-blind randomized clinical trial. J Appl Oral Sci.30:e20210538. doi: 10.1590/1678-7757-2021-0538. Erratum in: J Appl Oral Sci. 30:e2022er001. doi: 10.1590/1678-7757-2022er001.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAwwad A, Hamad R, Schiffner U, Splieth CH, Schmoeckel J (2023) Effect of Prevalence and Severity of Molar-Incisor Hypomineralization on Oral Health-Related Quality of Life: A Systematic Review and Meta-Analysis. Acta Stomatol Croat. 57(4):381-394. doi: 10.15644/asc57/4/8.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCarvalho MR, Molena KF, Regalo SCH, Gon\u0026ccedil;alves LMN, de Paula-Silva FWG, Vicioni-Marques F, de Vasconcelos PB, de Carvalho FK, de Queiroz AM (2024) Analysis of the stomatognathic system functions and mastication muscles in children affected by molar hypomineralization (MH): a cross-sectional study. Eur Arch Paediatr Dent. 25(5):669-676. doi: 10.1007/s40368-024-00925-3.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eGon\u0026ccedil;alves LMN, Molena KF, Carvalho MR, Regalo SCH, Si\u0026eacute;ssere S, de Paula-Silva FWG, de Queiroz AM, de Carvalho FK (2025) Children with unilateral molar-incisor hypomineralisation (MIH) may exhibit contralateral temporalis and masseter muscle hyperactivity: a cross-sectional study. Eur Arch Paediatr Dent. 26(5):891-901. doi: 10.1007/s40368-025-01006-9.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eWeerheijm KL (2003) Molar incisor hypomineralisation (MIH). Eur J Paediatr Dent. 4(3):114-20. PMID: 14529330.\u003c/li\u003e\n \u003cli\u003eAlyahyawi A, Alamoudi N, Baghlaf K (2025) Management of dental hypersensitivity in teeth affected with molar-incisor hypomineralization: an updated scoping review. Saudi J Health Sci. 14(2):109\u0026ndash;119. doi:10.4103/sjhs.sjhs_25_25\u003c/li\u003e\n \u003cli\u003eHjertberg E, Hajdarević A, J\u0026auml;levik B (2025) Desensitization treatment in MIH-affected teeth: a systematic review.\u0026nbsp;Eur Arch Paediatr Dent. 26(1):17-29. doi:10.1007/s40368-024-00934-2\u003c/li\u003e\n \u003cli\u003eMuniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC (2020) Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 30(3):323-333. doi: 10.1111/ipd.12602.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eIshikiriama SK, Moreira BN, Wang L, Bombonatti JFS, Zabeu GS, Rizzante FAP (2025) Clinical evaluation of the effect of 980 nm diode laser and fluoride varnish on dentin hypersensitivity. Braz Oral Res. 39:e077. doi: 10.1590/1807-3107bor-2025.vol39.077.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eRoriz VM, Santana M, Boaventura VL, Zanotto ED, Peitl Filho O, Dias DR (2024) Efficacy of Biosilicate Glass-ceramic and Fluoride Varnish in the Treatment of Dentin Hypersensitivity-A Randomized Controlled Clinical Trial. Oper Dent. 49(3):253-261. doi: 10.2341/23-077-C.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eDalmolin AC, Silva KR, Dechandt ICJ, Ribeiro KC, Gallo LS, Pochapski MT, Serbena FC, Dos Santos FA (2025) Efficiency of cavitary varnishes containing experimental bioglass particles in the occlusion of dentinal tubules. Odontology. 113(1):143-155. doi: 10.1007/s10266-024-00952-y.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eGhanim A, Elfrink M, Weerheijm K, Mari\u0026ntilde;o R, Manton D (2015) A practical method for use in epidemiological studies on enamel hypomineralisation.\u0026nbsp;Eur Arch Paediatr Dent. 16(3):235-246. doi:10.1007/s40368-015-0178-8\u003c/li\u003e\n \u003cli\u003eSchiff T, Delgado E, Zhang YP, Cummins D, DeVizio W, Mateo LR (2009) Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity. Am J Dent. 22 Spec No A:8A-15A.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLuyk NH, Beck FM, Weaver JM (1988) A visual analogue scale in the assessment of dental anxiety. Anesth Prog. 35(3):121-3.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBaik A, Alamoudi N, El-Housseiny A, Altuwirqi A (2021) Fluoride Varnishes for Preventing Occlusal Dental Caries: A Review.\u0026nbsp;Dent J (Basel). 9(6):64. doi:10.3390/dj9060064\u003c/li\u003e\n \u003cli\u003eBezerra SJC, de Figueiredo RM, Kairalla CA, Aoki IV, Hara AT, Scaramucci T (2026) Synergistic effect of sodium fluoride and encapsulated calcium lactate on dental erosion-abrasion prevention. J Dent. 166:106503. doi: 10.1016/j.jdent.2026.106503.\u003c/li\u003e\n \u003cli\u003eMagalh\u0026atilde;es AC, Kato MT, Rios D, Wiegand A, Attin T, Buzalaf MA (2008) The effect of an experimental 4% Tif4 varnish compared to NaF varnishes and 4% TiF4 solution on dental erosion in vitro. Caries Res. 42(4):269-74. doi: 10.1159/000135672.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eJettanacheawchankit S, Pongpradit T, Euapokai A, Eiamsakul A, Wongmoon K, Wayakanon K (2025) Evaluating the effects of remineralizing agents on initial carious lesions. Can J Dent Hyg. 59(1):18-28.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eOlgen IC, Sonmez H, Bezgin T (2022) Effects of different remineralization agents on MIH defects: a randomized clinical study. Clin Oral Investig. 26(3):3227-3238. doi: 10.1007/s00784-021-04305-9.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCamilotti V, Zilly J, Busato Pdo M, Nassar CA, Nassar PO (2012) Desensitizing treatments for dentin hypersensitivity: a randomized, split-mouth clinical trial. Braz Oral Res. 26(3):263-8. doi: 10.1590/s1806-83242012000300013.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAbd El-Fattah Mohamed H, Ezzeldin Mohamed D, Hassanein E, Salah El-Din Hamza HE (2025) In vivo and in situ evaluation of innovative approaches in dentin hypersensitivity treatment. BMC Oral Health. 25(1):593. doi: 10.1186/s12903-025-05865-y.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTirapelli C, Panzeri H, Soares RG, Peitl O, Zanotto ED (2010) A novel bioactive glass-ceramic for treating dentin hypersensitivity. Braz Oral Res. 24(4):381-7. doi: 10.1590/s1806-83242010000400002.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSilveira RE, Vivanco RG, de Morais RC, Da Col Dos Santos Pinto G, Pires-de-Souza FCP (2019) Bioactive glass ceramic can improve the bond strength of sealant/enamel? Eur Arch Paediatr Dent. 20(4):325-331. doi: 10.1007/s40368-018-0409-x.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eRamos FSES, Briso ALF, Albertinazzi L, Marchetti VM, Souza MT, Fagundes TC (2024) Efficacy of different in-office treatments for dentin hypersensitivity: randomized and parallel clinical trial. Braz Dent J. 35:e245487. doi:10.1590/0103-6440202405487\u003c/li\u003e\n \u003cli\u003eRoriz VM, Santana M, Boaventura VL, Zanotto ED, Peitl Filho O, Dias DR (2024) Efficacy of Biosilicate Glass-ceramic and Fluoride Varnish in the Treatment of Dentin Hypersensitivity-A Randomized Controlled Clinical Trial. Oper Dent. 49(3):253-261. doi: 10.2341/23-077-C. \u003cstrong\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cbr clear=\"all\"\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cbr clear=\"all\"\u003e\u0026nbsp;\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"clinical-oral-investigations","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cloi","sideBox":"Learn more about [Clinical Oral Investigations](http://link.springer.com/journal/784)","snPcode":"784","submissionUrl":"https://submission.nature.com/new-submission/784/3","title":"Clinical Oral Investigations","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Molar-Incisor Hypomineralization, Biosilicate, Dentin hypersensitivity, Dental enamel, Child","lastPublishedDoi":"10.21203/rs.3.rs-9180093/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9180093/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eObjectives: To evaluate the effectiveness of a 10% Biosilicate® suspension compared with fluoride varnish in reducing dentin hypersensitivity in molar–incisor hypomineralization (MIH)-affected teeth in children.\u003c/p\u003e\n\u003cp\u003eMaterials and Methods: This randomized, parallel-arm clinical trial included 42 children aged 6–12 years presenting at least one erupted first permanent molar affected by MIH and dentin hypersensitivity (SCASS ≥2). Participants were randomly allocated to fluoride varnish or 10% Biosilicate® groups using a concealed allocation sequence. One eligible tooth per child was included in the analysis. The assigned material was applied once weekly for four consecutive weeks. Hypersensitivity was assessed using the Schiff Cold Air Sensitivity Scale (SCASS) and the Visual Analogue Scale (VAS) at baseline, before each weekly application, and at 1, 2, 4, and 8 weeks after treatment completion.\u003c/p\u003e\n\u003cp\u003eResults: Forty-two children were randomized (22 in the fluoride varnish group and 20 in the Biosilicate® group completed the study). Both interventions significantly reduced hypersensitivity over time. However, Biosilicate® showed significantly greater reductions than fluoride varnish in VAS scores at 1, 2, 4, and 8 weeks, and in SCASS scores at 2, 4, and 8 weeks.\u003c/p\u003e\n\u003cp\u003eConclusions: Both treatments reduced dentin hypersensitivity in MIH-affected teeth. Biosilicate® showed a greater and more sustained desensitizing effect than fluoride varnish over the follow-up period.\u003c/p\u003e\n\u003cp\u003eClinical Relevance: Biosilicate® may represent an alternative desensitizing option for children with MIH-related dentin hypersensitivity, particularly when sustained symptom reduction is desired.\u003c/p\u003e\n\u003cp\u003eTrial registration: ClinicalTrials.gov, NCT07080645, registered on 2025-07-30.\u003c/p\u003e","manuscriptTitle":"Biosilicate and Fluoride Treatments in Molar Incisor Hypomineralization: a randomized trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-15 09:39:40","doi":"10.21203/rs.3.rs-9180093/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"118898458808917941461419262295765818262","date":"2026-05-12T05:42:13+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"336212642669724127229347149477223555919","date":"2026-05-11T17:45:44+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"185075259895374385413344280596900030714","date":"2026-05-11T15:56:13+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-07T15:24:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"24814606201428191524054245642389049691","date":"2026-05-07T06:00:13+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-05-06T09:54:07+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-03-23T08:32:28+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-03-23T08:31:48+00:00","index":"","fulltext":""},{"type":"submitted","content":"Clinical Oral Investigations","date":"2026-03-20T14:39:48+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"clinical-oral-investigations","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cloi","sideBox":"Learn more about [Clinical Oral Investigations](http://link.springer.com/journal/784)","snPcode":"784","submissionUrl":"https://submission.nature.com/new-submission/784/3","title":"Clinical Oral Investigations","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"eb9493c3-0c8c-4165-918c-28b45dbd1eb3","owner":[],"postedDate":"May 15th, 2026","published":true,"recentEditorialEvents":[{"type":"reviewerAgreed","content":"118898458808917941461419262295765818262","date":"2026-05-12T05:42:13+00:00","index":16,"fulltext":""},{"type":"reviewerAgreed","content":"336212642669724127229347149477223555919","date":"2026-05-11T17:45:44+00:00","index":15,"fulltext":""},{"type":"reviewerAgreed","content":"185075259895374385413344280596900030714","date":"2026-05-11T15:56:13+00:00","index":14,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-07T15:24:06+00:00","index":13,"fulltext":""},{"type":"reviewerAgreed","content":"24814606201428191524054245642389049691","date":"2026-05-07T06:00:13+00:00","index":12,"fulltext":""},{"type":"reviewersInvited","content":"6","date":"2026-05-06T09:54:07+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-15T09:39:42+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-15 09:39:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9180093","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9180093","identity":"rs-9180093","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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