Phase II, proof-of-concept randomized controlled trial to evaluate dental caries preventive effects of fluoridated bottle water - dental health benefits of fluoride in drinking water have never been…

Phase II, proof-of-concept randomized controlled trial to evaluate dental caries preventive effects of fluoridated bottle water - dental health benefits of fluoride in drinking water have never been tested in a randomized controlled trial (RCT). Instead, results from observational studies and a few non-randomized, community intervention studies were sufficient to justify addition of fluoride to many public water systems during the 20TH century and to defend against fluoridation's critics. However, growth in fluoridated public water systems has stalled, leaving 100 million americans living in places that do not have fluoridated water and which probably never will. A related problem is that, nationwide, 15% of children do not drink TAP water for reasons ranging from consumer preference to distrust of public water. One solution, capitalizing on consumers' demand for bottled water, is to increase consumption of fluoridated bottled water. However, RCT evidence of dental health benefits of fluoridated bottled water will be essential if public health is to embrace IT as a strategy to extend fluoridation. In the absence of a precedent, and in the face of uncertainty as to compliance and likely effect size of the intervention, a fully powered RCT is premature. We instead propose a phase II, proof-of-concept RCT to evaluate dental caries preventive effects of fluoridated bottled water in a community not served by water fluoridation. The primary recruitment population is ~470 babies born during a one-year period in kinston, NC, the state's community with the largest non-fluoridated public water system where caries prevalence exceeds the state average. In households where measured content of fluoride in TAP water is