Xylitol for Caries Prevention in Inner-City Children
Project Number: R40 MC 07838-03 Project Date: 1/1/2007 Grantee: Case Western Reserve University Department/Center: Community Dentistry/Dental Medicine
Final Report
Pending
Principal Investigator
Suchitra Nelson Ph.D., Associate Professor, Case Western Reserve University Community Dentistry/Dental Medicine, 10900 Euclid Avenue Cleveland, Ohio 44106-1712 sxn15@case.edu
Abstract
This randomized controlled clinical trial addresses the prevention of dental caries (tooth decay) in inner-city school children using xylitol-containing snacks. Dental caries disproportionately affects poor and minority children with a significant proportion of treatment costs borne by Medicaid. The current best practices of oral health education, tooth brushing, topical fluorides and dental sealants have a more limited impact in children with the highest tooth decay rates than in children with lower rates as the newest research shows that an antimicrobial agent is required. Thus, addressing disparities, improving child health (MCH strategic research issue # II & IV), and reducing caries rates (Healthy People 2010) are key public health objectives. Xylitol is safe, FDA approved effective preventive agent, but poorly utilized in the U.S. The goal of this study is to establish the use of an antimicrobial agent, delivered via xylitol gummy bear snacks at school, to reduce the caries rates in the permanent teeth of children from Kindergarten to 2nd grade. This age group is chosen because prevention works best when the teeth are just erupting. The aims are (1) to reduce the incidence of caries in first permanent molars and other permanent teeth beyond the effects of oral health education, fluoride varnish, and sealants; and (2) to determine the preventive effect of xylitol beyond the termination of its use. Six hundred children (5-6 years, >95% on free/reduced school lunch, 94% African-American) attending kindergarten in 5 East Cleveland City Schools will be recruited and randomized into the xylitol or the placebo (sorbitol) control groups. Gummy bears (xylitol/placebo) will be given 3 times daily during Kindergarten, and within the supervised school environment. All children will receive the current best public health practices of oral health education, provision of tooth brush and fluoridated paste, fluoride varnish, and dental sealants as recommended by the U.S. Preventive Services Task Force and the Surgeon General. During the 30 month follow-up until second grade, all cases of caries will be recorded every year. Data analysis for testing the study aims includes the generalized estimating equations (GEE) models. The sample size provides greater than 80% power to compare the two groups in terms of the two study aims. The results of this study will be useful in adding a new public health strategy in the prevention of dental caries for children with the greatest vulnerability to tooth decay.
Publications
Pending
Keywords
oral health, community based preventive health, school age children, minority groups.
