Water From Bottles to Establish Strong Teeth (waterBEST)

  • STATUS
    Recruiting
  • End date
    Jun 23, 2026
  • participants needed
    200
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 4 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Dental Caries in Children
Treatment Fluoridated bottled drinking water, Non-fluoridated drinking water
Clinical Study IdentifierNCT04893681
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The parent/guardian/caregiver understands and consents to procedures described in parental permission and consent form
Child is aged 2 months to 6 months at the screening visit
Child either drinks water (either plain water, or water mixed with something) or is expected to drink water by their first birthday, as reported by the parent/guardian/caregiver at the screening visit
The child's primary dwelling at the screening visit has tap water that contains ≤0.60 mg/L F, based on measurement of a tap water sample made at Dr. Godebo's laboratory. For children who live at more than one dwelling, the primary dwelling is defined as the one at which they usually sleep at least four nights per week

Exclusion Criteria

Child has serious illness/es requiring frequent inpatient hospitalization, as reported by the parent/ guardian/caregiver at the screening visit
Child's birth weight was less than 1,500 g (3 pounds 5 ounces)
Child's gestational age was less than 34 weeks
Child uses fluoride supplements, as reported by the parent/ guardian/caregiver at the screening visit
Parent/guardian/caregiver states at the screening visit the child will initiate fluoride supplementation before the child's 4th birthday
The parent/ guardian/caregiver anticipates that the child will move to an address more than 30 miles from Kinston, NC before the child's 4th birthday
The investigators determine that a child living at the same primary dwelling has already been enrolled in the study. (This means that if two or more children fulfilling the inclusion criteria live at the primary dwelling, the parent will be asked to select one such child to be the study participant.)
Anything that, in the opinion of the principal investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
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