Milgrom P, Ly KA, Tut OK, Mancl L, Roberts MC, Briand K, et al. Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy. Arch Pediatr Adolesc Med 2009;163:601-7.
Question
Among very young children at high risk for early childhood caries (ECC), will a xylitol pediatric topical oral syrup reduce the incidence of dental caries?
Design
Double-blind randomized controlled trial.
Setting
Communities in the Republic of the Marshall Islands with very high ambient ECC rates.
Participants
A total of 108 children, aged 9 to 15 months, were screened, and 100 were enrolled.
Intervention
Xylitol topical oral syrup (administered by their parents) twice a day (2 xylitol [4.00-g] doses and 1 sorbitol dose) (Xyl-2X group) or thrice per day (3 xylitol [2.67-g] doses) (Xyl-3X group) vs a control syrup (1 xylitol [2.67-g] dose and 2 sorbitol doses) (control group).
Outcomes
Primary outcome was the number of decayed primary teeth.
Main Results
94 children (mean age 15.0 months at randomization) with at least 1 follow-up examination were included in the intent-to-treat analysis. The mean (SD) follow-up period was 10.5 (2.2) months. Fifteen of the 29 children in the control group (51.7%) had tooth decay compared with 13/32 in the Xyl-3X group (40.6%) and 8/33 children in the Xyl-2X group (24.2%). The mean (SD) numbers of decayed teeth were 1.9 (2.4) in the control group, 1.0 (1.4) in the Xyl-3X group, and 0.6 (1.1) in the Xyl-2X group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl-2X group (relative risk, 0.30; 95% confidence interval, 0.13-0.66; P = .003) and in the Xyl-3X group (0.50; 0.26-0.96; P = .04). No statistical difference was noted between the 2 xylitol treatment groups (P = .22).
Conclusions
Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in reducing early childhood caries progression.
Commentary
Worldwide, pediatric dental caries is a prevalent, persistent, and consequential disease characterized by a low-level chronicity that often belies its significance to individual children and those close to them. It is rampant within some subpopulations, both those of poverty and those of emerging affluence. In the United States, more than 2 in 5 poor children ages 2 to 5 years experience “early childhood caries” (ECC), and nearly half of those affected experience the severe form of this preventable condition.1 The extreme prevalence, rapidly increasing incidence, and very early onset of ECC in the Marshall Island population studied by Milgrom et al provide excellent conditions to validate the short-term (1 year) salutary impact of a xylitol intervention (16-24 g per day in divided doses) within a small population (n = 100) at high risk. A significant difference in numbers of newly decayed teeth, if not in the percentage of children who experienced any caries progression, suggests a high potential clinical utility to this intervention. Yet we must be cautious about extrapolation of these results to more typical child populations. Prior evidence for cariostatic benefits of xylitol was sufficiently strong to ethically mandate inclusion of low-level xylitol exposure within the “control” group. This inclusion, however, does not diminish the observation that xylitol holds strong promise as a pharmacologic adjunct in the bio-behavioral management of dental caries in early childhood.
Reference
1. 1Iida H, Auinger P, Billings RJ, Weitzman M. Association between breastfeeding and early childhood caries in the United States. Pediatr. 2007;120:e944–e952.
College of Dental Medicine, Columbia University, New York, New York