Cluster-randomized Xylitol Toothpaste Trial for Early Childhood Caries Prevention

Purpose: The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries (ECC) and reduce mutans streptococci.

Methods: In this cluster-randomized efficacy trial, 196 four- to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste. We hypothesized that there would be no difference in efficacy between the two types of toothpaste. The primary outcome was the surface-level primary molar caries increment (d2-3 mfs) after six months. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children), and two classrooms were assigned to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering.

Results: There was no difference between the two groups in baseline or end-of-trial mean d2-3 mfs. The mean d2-3 mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d2-3 mfs, respectively), but the difference was not significant (95% confidence interval: -0.17, 2.37; P=.07). No adverse effects were reported.

Conclusion: After six months, brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population.