Abstract
AIM: Early childhood caries (ECC) remains a significant global health challenge. While fluoride-based treatments are the standard, bioactive glass (BAG) has emerged as a promising alternative for caries prevention. This clinical trial aimed to evaluate the effectiveness of a fluoride-free BAG-based toothpaste compared to a fluoride toothpaste in preventing ECC. METHODS: This double-blinded, multicentre, randomized controlled trial enrolled 1063 children aged 3 to 4 years from 12 kindergartens in Hubei, China. Participants were randomly assigned to either the test (fluoride-free toothpaste containing 7.5% (w/w) BAG) or the control (fluoride toothpaste containing 800 ppm F) group. The primary outcomes were caries increment, measured as changes in decayed, missing, and filled teeth (dmft) and surfaces (dmfs) scores, and caries incidence after 27 months. Secondary outcomes included caries increment and incidence assessed at 12 months of follow-up. RESULTS: Baseline characteristics were well balanced between the test and control groups. Both groups demonstrated progressive increases in caries measures during the follow-up periods, though no statistically significant differences emerged between the interventions. At 27 months, caries increment and incidence were comparable between the test and control groups (P > .05 for all comparisons). Similar patterns were observed at 12 months, with both groups showing equivalent caries progression. No adverse events were reported during the study period. CONCLUSIONS: This trial revealed that fluoride-free toothpaste containing 7.5% (w/w) BAG exhibited comparable efficacy to 800 ppm fluoride toothpaste in preventing ECC over 27 months. However, both interventions were associated with substantial caries progression (mean dmft increment >2.0), indicating limited effectiveness in preschool children.