Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy.
OBJECTIVE
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.


METHODS
Double-blind randomized controlled trial.


METHODS
Communities in the Republic of the Marshall Islands.


METHODS
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 x 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).


METHODS
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-3x group (40.6%) and eight of 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 preventing early childhood caries.
Milgrom
Peter
P
Northwest Center to Reduce Oral Health Disparities, Department of Dental Public Health Sciences, School of Dentistry, University of Washington, Seattle, WA 98195-7475, USA. dfrc@u.washington.edu
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Kiet A
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Tut
Ohnmar K
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Mancl
Lloyd
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Roberts
Marilyn C
MC
Briand
Kennar
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Gancio
Mary Jane
MJ
D000284:Administration, Oral; D004245:DMF Index; D003731:Dental Caries / Q000453:epidemiology / Q000517:prevention & control*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D008849:Micronesia / Q000453:epidemiology; D010033:Otitis Media / Q000453:epidemiology / Q000517:prevention & control; D016012:Poisson Distribution; D013012:Sorbitol / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014993:Xylitol / Q000008:administration & dosage / Q000627:therapeutic use*
D004304:Dosage Forms; D013012:Sorbitol; D014993:Xylitol