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.
Listed is descending order by year published.
Heima M, Lee W, Milgrom P, Nelson S. Caregiver’s educational level and child’s dental caries in African Americans: a path analytic study. Caries Res. 2015;49(2):177-183.
Lee W, Spiekerman C, Heima M, et al. The effectiveness of xylitol in a school-based cluster-randomized clinical trial. Caries Res. 2015;49(1):41-49.
Nelson S, Mandelaris J, Ferretti G, Heima M, Spiekerman C, Milgrom P. School screening and parental reminders in increasing dental care for children in need: a retrospective cohort study. J Public Health Dent. 2012 Winter;72(1):45-52.
Nelson S, Milgrom P. Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States. Contemp Clin Trials. 2012 Jan;33(1):60-6.
Nelson S, Eggertsson H, Powell B, Mandaleris J, Ntragatakis M, Richardson T, Ferretti G. Calibration of dental examiners in the ICDAS criteria for a caries prevention community trial. Community Dent Health. 2011 Sep;28(3):238-42. PMID: 21916361
Oral Health, Health Disparities, School Outcomes & Services