A Three-Year Randomized Controlled Trial in 6-Year-Old Children on Caries-Preventive Strategies in a General Dental Practice in the Netherlands

Abstract

A parallel-randomized controlled trial on caries-preventive strategies was conducted in a general dental practice with a mixed socioeconomic background patient population. The aim of this study was to test the hypothesis that, compared to regular care consisting of check-ups twice a year with professional fluoride applications and pit and fissure sealants in all permanent molars, a larger caries-preventive effect can be achieved by following a non-operative caries treatment and prevention (NOCTP) strategy or by following, in addition to regular care, an increased number of professional topical fluoride applications (IPFA). A total of 230 children (6.0 years ± 3 months of age) were randomly assigned to the two experimental groups or the control group. After 3 years, 179 participants remained in the study (54 NOCTP, 62 IPFA and 63 control). The children were examined at baseline and at 3 years by the same experienced examiner, who was blinded for the allocation of the children. Caries was scored clinically at the D₃ level. Per protocol analysis revealed a mean DMFS increment after 3 years of 0.15 (95% CI -0.05 to 0.35) for NOCTP, 0.34 (95% CI 0.11 to 0.54) for IPFA and 0.47 (95% CI 0.26 to 0.68) for the control group. To account for missing data, multiple imputation was used, after which the mean DMFS increment was 0.11 (95% CI -0.05 to 0.27) for NOCTP, 0.29 (95% CI 0.11 to 0.46) for IPFA and 0.40 (95% CI 0.21 to 0.55) for the control group. Testing the differences with independent samples t test revealed a lower caries increment in the NOCTP group compared to the control group. ANCOVA was used to correct for differences in baseline dmfs, socioeconomic status and perceived dental hygiene burden. The ΔDMFS effect size between the NOCTP and the control group dropped, losing statistical significance (p = 0.06). Although the results in this study are promising, it has yet to be established in a larger study whether NOCTP has the ability to be effective in regular dental practice with a mixed socioeconomic status population.