Comparison of clinical effectiveness of conventional and self-etch sealant: a split mouth randomized controlled trial [version 3; peer review: 2 approved]

Background: Self-etching has been shown to be beneficial compared to the other resin sealants especially in pediatric practice. The present in-vivo study was designed to clinically evaluate the sealing ability and retention of the self-etching sealant compared to the conventional resin sealant. The aim was to evaluate and compare the retention and marginal integrity of the self-etch and acid etch sealant materials at three, six and twelve-month follow up. Methods: The study was designed as a double blinded, split mouth randomized controlled trial, . In total, 35 children (70 teeth) between 7 and 10 years of age formed part of the study. Group 1 received acid-etch sealant and Group 2 received self-etch sealants. The study participants and the investigator who performed the statistical analysis were blinded to the treatment allocation. All the samples were evaluated at 3, 6, and 12 months. The inter-group and intragroup comparison were carried out using the Chi-Square test and Friedman test with level of significance set at 5% and the P value less than 0.05. Results: Complete retention of sealants was observed in 34.5% of conventional acid etch (group 1) and 22.9% of self-etch samples (group 2) whereas complete loss of sealants were seen in 11.4% of group 1 and 20% of the group 2 samples and intergroup comparison of retention failure was non-significant (p=0.135). In total, 85.7% of the group 1 and 82.9% of the group 2 samples exhibited good marginal integrity with no clinical changes in the enamel around the margins but this was not statistically significant (p=0.5). Conclusions: Sealants with fewer procedural steps and those which provide adequate retention would be ideal for use in children. Thus, self-etch sealants have been found to be effective and efficient as a sealant in the present in-vivo study. Clinical Trials Registry, India registration: CTRI/2019/03/018343 (29/03/2019).