NCT04893681

Water From Bottles to Establish Strong Teeth

Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
OTHER	Fluoridated bottled drinking water	Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.
OTHER	Non-fluoridated drinking water	Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.

Timeline

• Start date: 2022-04-14
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2021-05-19
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States