A Randomized Controlled Trial to Arrest Dentine Caries: 12-month Result

Abstract

Objectives: The objective of this study is to compare the effectiveness of two topical fluoride application protocols in arresting coronal dentine caries of primary teeth among preschool children. Methods: This is a double-blind, two-arm, parallel-design randomized controlled trial. Children aged 3-4 years old who had at least one coronal dentine carious lesion were randomly allocated into two groups: Group A received semi-annual application of a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish; and Group B received semi-annual application of a 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP). One examiner performed oral examinations every six months to assess whether the treated lesions had been arrested. Chi-square test, intention-to-treat analysis and multilevel logistic regression analysis were undertaken. Results: Four hundred and eight children (48.5% boy) with 1,833 active carious tooth surfaces were recruited at baseline. No statistically significant differences were found between groups regarding the background, oral health-related behaviours, oral hygiene status and baseline caries status. After 12 months, 402 (98.5%) children remained in the study. The caries arrest rates at surface level were 45% and 52% for Group A and Group B, respectively (p<0.001). Results of the multilevel logistic regression showed protocol of Group B (AgNO3 plus NaF with fTCP) had a higher chance to arrest active dentine caries (OR=1.50, p=0.009). Carious lesions on buccal/palatal surfaces, in anterior teeth and in children who brushed at least twice daily had higher chance to be arrested (OR=2.56, 1.47 and 1.58 respectively, p<0.05). Conclusions: Semi-annual application of a 25% AgNO3 solution followed by a 5% NaF varnish with fTCP is more effective in arresting dentine caries in primary teeth than the semi-annual application of a 25% AgNO3 solution followed by a 5% NaF varnish.