Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST).

ABSTRACT:

Background

Fluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluoridated public water system and many others do not drink tap water. This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses its potential dental caries preventive efficacy when delivered in bottles.

Methods

waterBEST is a phase 2b proof-of-concept, randomized, quadruple-masked, placebo-controlled, parallel-group trial designed to estimate the potential efficacy of fluoridated versus non-fluoridated bottled water to prevent dental caries incidence in the first 4 years of life. Two hundred chi

SUBMITTER: Sanders AE 

PROVIDER: S-EPMC10913546 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature