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Aim: To evaluate the effect of xylitol- and xylitol/fluoride-containing lozenges on approximal caries development in young adolescents with high caries risk.

Study design: A 2-year double-blind trial with two parallel arms and a nonrandomized reference group.

Material and methods: One hundred and sixty healthy 10- to 12-year-old children with high caries risk were selected. After informed consent, they were randomly assigned into a xylitol and a xylitol/fluoride group. They were instructed to take two tablets three times a day (total xylitol and fluoride dose 2.5 g and 1.5 mg, respectively). The compliance was checked continuously and scored as good, fair, or poor. A reference no-tablet group was also selected (n = 70) for group comparison. The outcome measure was approximal caries incidence.

Results: The dropout rate was 28%, and 41% exhibited a good compliance with the study protocol. No statistically significant differences in caries incidence could be found between the study groups (P > 0.05). Among a subgroup of children who demonstrated good compliance, the mean DeltaDMFSa value was significantly lower in the xylitol/fluoride group compared to the xylitol group, 1.0 +/- 2.3 vs. 3.3 +/- 4.6 (P < 0.05), while no difference could be displayed between any of the study groups and the reference group (P > 0.05).

Conclusions: The results from this 2-year trial did not support a self-administered regimen of xylitol- or xylitol/fluoride-containing lozenges for the prevention of approximal caries in young adolescents with high caries risk.