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July 6, 2009

Xylitol Pediatric Topical Oral Syrup to Prevent Dental Caries: A Double-blind Randomized Clinical Trial of Efficacy

Author Affiliations

Author Affiliations: Northwest Center to Reduce Oral Health Disparities, Department of Dental Public Health Sciences, School of Dentistry (Drs Milgrom, Ly, and Mancl), and Department of Environmental & Occupational Health Sciences, School of Public Health and Community Medicine (Dr Roberts), University of Washington, Seattle; and Ministry of Health, Majuro, Republic of the Marshall Islands (Drs Tut, Briand, and Gancio).

Arch Pediatr Adolesc Med. 2009;163(7):601-607. doi:10.1001/archpediatrics.2009.77

Objectives  To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study.

Design  Double-blind randomized controlled trial.

Setting  Communities in the Republic of the Marshall Islands.

Participants  One hundred eight children aged 9 to 15 months were screened, and 100 were enrolled.

Intervention  Children were randomized to receive xylitol topical oral syrup (administered by their parents) twice a day (2 xylitol [4.00-g] doses and 1 sorbitol dose) (Xyl-2 × group) or thrice per day (3 xylitol [2.67-g] doses) (Xyl-3× group) vs a control syrup (1 xylitol [2.67-g] dose and 2 sorbitol doses) (control group).

Main Outcome Measures  The primary outcome end point of the study was the number of decayed primary teeth. A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report.

Results  Ninety-four children (mean [SD] age, 15.0 [2.7] 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 29 of the children in the control group (51.7%) had tooth decay compared with 13 of 32 children in the Xyl-3× group (40.6%) and eight of 33 children in the Xyl-2× 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-3× group, and 0.6 (1.1) in the Xyl-2× group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl-2× group (relative risk, 0.30; 95% confidence interval, 0.13-0.66; P = .003) and in the Xyl-3× group (0.50; 0.26-0.96; P = .04). No statistical difference was noted between the 2 xylitol treatment groups (P = .22).

Conclusion  Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries.

Trial Registration  isrctn.org identifier: ISRCTN84269958