Fluoride varnish efficacy in preventing early childhood caries

Abstract

To determine the efficacy of fluoride varnish (5% NaF, Duraphat, Colgate) added to caregiver counseling to prevent early childhood caries, we conducted a two-year randomized, dental-examiner-masked clinical trial. Initially, 376 caries-free children, from low-income Chinese or Hispanic San Francisco families, were enrolled (mean age +/- standard deviation, 1.8 +/- 0.6 yrs). All families received counseling, and children were randomized to the following groups: no fluoride varnish, fluoride varnish once/year, or fluoride varnish twice/year. An unexpected protocol deviation resulted in some children receiving less active fluoride varnish than assigned. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, p < 0.01. Analyzing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, p < 0.01. Caries incidence was higher for 'counseling only' vs. 'counseling + fluoride varnish assigned once/year' (OR = 2.20, 95% CI 1.19-4.08) and 'twice/year' (OR = 3.77, 95% CI 1.88-7.58). No related adverse events were reported. Fluoride varnish added to caregiver counseling is efficacious in reducing early childhood caries incidence.

Figure 1

Flow of study participants. Children with and without dental caries at each examination by intended (randomized) fluoride varnish (FV) treatment group. * 27 children with no caries at 12 months were not seen at 24 months; 19 children with a 24-month examination missed the 12-month examination.

Figure 2

Caries incidence at last follow-up examination by intended treatment group and number of active fluoride varnish applications (n = 280). * 3 active applications + one child with 4 active applications. Intended groups are the groups randomized to receive 0, 2, or 4 fluoride varnish applications. Active groups are the children stratified by number of actual fluoride-containing varnish applications received (see text and APPENDIX).