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).

"Declarations Ethics approval and consent to participate {24}The protocol is approved by the IRB of the University of North Carolina at Chapel Hill (IRB #20-3273) and regulatory bodies including NIDCR’s Data Safety and Monitoring Board. Written, informed consent to participate will be obtained from all parents or legal guardians. Consent for publication {32}The model Parental Permission Consent Form is uploaded. Competing interests {28}The authors declare they have no competing interests. Competing interests {28} The authors declare they have no competing interests."

"Funding {4} The National Institute for Dental and Craniofacial Research of the US National Institutes of Health funded the study."

"Trial registration ClinicalTrials.gov NCT04893681. Registered on March 2022. Last update posted on 10 October 2023. https://clinicaltrials.gov/study/NCT04893681?cond=Dental%20Caries%20in%20Children&term=fluoride&locStr=North%20Carolina,%20USA&country=United%20States&state=North%20Carolina&distance=50&rank=1"