A prospective, randomized, split-mouth clinical study by thetwo previously trained and calibrated pediatric dentists without blinding operators and patients due to different protocols in both treatment groups. An SDF + potassium iodide (KI) and SDF + KI + glass ionmer cement(GIC) on International Caries Detection and Assessment System (ICDAS) 1/2 molar was received by each patient on either sideof mouth. The local Ethics Committee approved this study. Sample size calculation was not performed due to the lack of published studies on the longevity of SMART sealant on MIH-affected molarsand the absence of research on the apparent difference between the effectiveness of SMART and SDF treatments in preventing further caries and sensitivity. These were children between the ages of 6 years to 13 years, who visited the Pediatric Dentistry Clinic at XX University School of Dentistry for routine exams and treatment between July 2019 to May 2020. They were in good health and had at least two fully erupted permanent first molars with MIH as per the European Academy of Pediatric Dentistry, ICDAS code 1/2. This study recorded 12 months of treatment outcomes on hypomineralised molars of 48 children with a follow-up of three years. Children were excluded with specific syndromes associated with enamel malformation, lack of cooperation, ongoing orthodontic treatment, and teeth with ICDAS 3/4/5/6 lesions, existing restorations, fluorosis, or pulpal symptoms. Mann-Whitney U Test was used to assess differences between independent groups (SDF and SMART) and the Friedman Test between dependent groups at different time points. Kaplan-Meier analysis to evaluate the cumulative survival of SMART sealants and survival of caries-free hypomineralised molars in both groups. Chi-Square test was used to compare the success percentages of the SDF and SMART groups. To assess the changes in success percentages at three different time intervals for the caries preventive effect of SDF and SMART, and to evaluate the retention percentages for the SMART group. McNemar's test with a Bonferroni correction was used for significant differences. Cohen's kappa test indicated that the inter-examiner reliability determining the presence of MIH was 0.87. The intra-examiner reliability for US Public Health Service (USPHS)-Modified criteria was 0.90. The statistical significance level was set at p < 0.05 for all statistical analyses. At 12, 24 and 36 months the caries preventive effect was 100%, 67.9%, and 65.4% for SDF + KI-treated teeth; and 100%, 97.6%, and 94.7% for SMART (SDF + KI + GIC) respectively. During the recall period, there was no substantial difference in hypersensitivity scores between the groups. There was no hypersensitivity in teeth at 18 months and beyond. Compared to the baseline Schiff Cold Air Sensitivity Scale (SCASS) score 26 molar with initial hypersensitivity to hypomineralisation had a massive reduction at evaluation periods. The mean survival probabilities for the caries-preventive effect were considerably lower in SDF + KI-treated teeth (31.01 months) than in SMART-treated teeth (35.61 months) (p < 0.001). Considering the limitation of the study, both SMART (SDF + KI + GIC) sealants and 6-monthly application of SDF + KI, provided similar and substantial levels of desensitisation on the permanent MIHmolars. When used as a sealing material on non-cavitated permanent MIHmolars, the clinical retention rate for SMART was 88.7%, 73.1%, and 66.6% at 1, 2, and 3 years respectively. The caries preventive effect of SMART (SDF + KI + GIC) sealants was superior to SDF + KI application in hypomineralised teeth, however, a long-term monitoring and review is essential due to the gradual decrease in retention of SMART sealants.
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