Office of Epidemiology and Research, Division of Research

Advancing Applied MCH Research

Xylitol for Acute Otitis Media & Early Childhood Caries

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Project Number: R40 MC 03622-03
Grantee: University of Washington
Department/Center: Dental Public Health Sciences
Project Date: 09/01/2004

Final Report

Xylitol for Acute Otitis Media & Early Childhood Caries Final Report (PDF) Exit Disclaimer

Principal Investigator

Peter Milgrom, DDS
University of Washington Box 357475
Seattle, WA  98195-7475
Phone: (206) 543-2034


  • Perinatal/Infancy (0-12 months)
  • Toddlerhood (13-35 months)


  • Asian/Pacific Islander


This public health feasibility study is in response to MCHB Strategic Research Issue #II, to eliminate health disparities and barriers to health care access for MCH populations" This community-based study addresses the prevention of Acute Otitis Media (AOM) and Early Childhood Caries (ECC) using xylitol syrup among disadvantaged children. AOM and ECC are two of the most common diseases in children costing billions of dollars annually and disproportionately affect those of low socio-economic status. Reductions in both diseases are objectives of Healthy People 2010. Xylitol is safe and approved by FDA for use as a sugar substitute since 1960's. We propose a 12-month study to evaluate the effect of xylitol on AOM and ECC in children in the first 2 years of life. The goal is to establish the feasibility of using xylitol syrup to reduce the incidence of AOM and ECC. The aims are to verify the protective effect of xylitol syrup in this age group and to determine the relationship between the frequency of xylitol application and the magnitude of protection against ECC and AOM. The secondary outcome measure will be the amount of antibiotics used to treat AOM. One hundred 9-15 month old children in the Republic of the Marshall Islands [in free association with the U.S. and qualified under Title V of the Social Security Act] will be recruited and randomized into the placebo control group or one of 3 xylitol groups, 1, 3, or 5 xylitol doses per day. During the 12-month follow-up, all cases of AOM will be recorded. Cases of ECC will be ascertained at 6 and 12 month. The sample size allows for adequate evaluation of the acceptability of the protocol. Power to detect a linear relationship between the number of xylitol applications and incidence of AOM or ECC is 88% - 99%. The use of xylitol will be viable for MCH program if effectiveness at 1 to 3 doses per day can be ascertained. Extensive community support in RMI has been developed for this study.


Listed is descending order by year published.

Milgrom P, Ly KA, Tut OK, Mancl L, Roberts MC, Briand K, Gancio MJ. Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy. Arch Pediatr Adolesc Med. 2009 Jul;163(7):601-7.

Milgrom P, Rothen M, Milgrom L. Developing public health interventions with xylitol for the US and US-associated territories and states. Suom Hammaslaakarilehti. 2006 May 15;13(10-11):2-11.


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