ASSESSMENT OF THE EFFICACY OF FLUORIDE VARNISH VERSUS ACIDULATED PHOSPHATE FLUORIDE GEL IN PREVENTING DENTAL CARIES IN SCHOOLCHILDREN: A 24-MONTH RANDOMIZED CONTROLLED TRIAL

Background: Dental caries remains a significant public health problem among children globally. Professionally applied topical fluorides, such as fluoride varnish (FV) and acidulated phosphate fluoride (APF) gel, are cornerstones of caries prevention, but evidence from direct, long-term, placebo-controlled comparisons is continuously needed to guide clinical and public health practice.
Methods: A three-arm, parallel-group, double-blind, randomized controlled trial was conducted in 450 schoolchildren
aged 6-8 years with a high risk for caries. Participants were randomly allocated into three equal groups (n=150 each):
Group A received 5% sodium fluoride varnish (FV), Group B received 1.23% APF gel, and Group C received a placebo
varnish. Interventions were applied biannually. The primary outcome was the 24-month increment in the Decayed,
Missing, and Filled Surfaces (DMFS) index, assessed by calibrated examiners blinded to the treatment allocation.
Secondary outcomes included patient acceptance and reported adverse effects.
Results: After 24 months, 418 children (92.9%) completed the study. The mean DMFS increment was significantly
lower in the fluoride groups compared to the placebo group. The mean DMFS increment (± SD) was 0.9 ± 1.0 in the FV group and 1.2 ± 1.1 in the APF gel group, compared to 2.5 ± 1.8 in the placebo group (p < 0.001 for both fluoride groups vs. placebo). The prevented fraction was 64.0% for FV and 52.0% for APF gel. The difference in DMFS increment between the FV and APF gel groups was not statistically significant (p = 0.134). Patient acceptance was significantly higher for the varnish application (92% rated ‘good’ or ‘excellent’) compared to the gel (75%) (p = 0.002). No significant adverse effects were reported.
Conclusion: Both fluoride varnish and APF gel are highly effective in preventing dental caries in high-risk
schoolchildren. Fluoride varnish demonstrated a slightly higher, though not statistically significant, preventive effect
and was associated with better patient acceptance, suggesting it may be a preferable option for community-based public health programs.