Status:
ACTIVE_NOT_RECRUITING
Water From Bottles to Establish Strong Teeth
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Tulane University
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Dental Caries in Children
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief 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-...
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 bot...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- The child's primary dwelling at the screening visit has tap water that contains \>0.60 mg/L F and the parent/guardian/caregiver expresses a preference that the child drink tap water, not bottled water, for the child's first four years of life. 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.
- 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.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04893681
Start Date
April 14 2022
End Date
June 1 2029
Last Update
July 3 2025
Active Locations (1)
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1
Division of Pediatric and Public Health, UNC Adams School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7455