This is a proof-of-concept, randomized, double-masked, placebo controlled, parallel group study evaluating dental caries-preventive effects of fluoridated bottled water compared to non-fluoridated bottled water in 4-year-old children. Children will be allocated at random to receive either fluoridated or non-fluoridated sourced from two local public water systems. The water will be packaged into 5-gallon bottles and delivered to households during a 3½ year intervention period. During the intervention period, parents/guardians/caregivers will be interviewed quarterly to monitor children's general health and a dental screening will be conducted annually. Children's fingernail and toenail clippings will be collected annually and analyzed to determine the fluoride content as a biomarker of total fluoride intake. Dental caries experience, the primary endpoint, will be determined once in a dental examination conducted by a study dentist close to the time of the child's 4th birthday. For the primary aim, a least-squares, generalized linear model will estimate efficacy and its one-tailed, upper 80% confidence limit using the number of decayed, missing and filled primary tooth surfaces as the dependent variable.
The waterBEST study is a proof-of-concept, randomized, double-masked, placebo controlled, parallel group study evaluating dental caries-preventive effects of fluoridated bottled water compared to non-fluoridated bottled water in 4-year-old children.