Effectiveness of applying proximal enamel caries with fluoride-releasing sealant and fluoride varnish on caries progression in permanent teeth: A 12-month split-mouth randomized clinical trial.

BACKGROUND: Few studies report on managing initial proximal caries with sealants, and no reports focus on fluoride-releasing sealants. AIM: To compare the effectiveness between applications of a fluoride-releasing sealant and fluoride varnish on proximal enamel caries to control caries progression in permanent teeth. DESIGN: This was a split-mouth randomized controlled trial in forty-four 11- to 16-year-old children with radiographic caries in at least one contralateral pair of teeth with proximal enamel caries. The lesions were evaluated using DIAGNOdent and were also assessed visually after tooth separation. The lesions in each subject were randomly sealed with a fluoride-releasing sealant (Helioseal® F) or applied with fluoride varnish (Duraphat®). The fluoride varnish-treated lesion was reapplied at 3 and 6 months. Clinical examination, bitewing radiograph evaluation, and DIAGNOdent assessment were performed at 6 and 12 months. The caries progression outcome variables were regression, no change, and progression. The data were analyzed with the McNemar-Bowker test. RESULTS: Radiographic examination and DIAGNOdent assessment demonstrated no significant differences in the percentages of regression, no change, or progression at the 12-month follow-up (p > .05). CONCLUSION: Applications of a fluoride-releasing sealant and of fluoride varnish three times resulted in a nonsignificant difference in caries progression of initial proximal caries at the 12-month follow-up.