Bottled water with fluoride put to the test against childhood cavities
NCT ID NCT04893681
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether fluoridated bottled water prevents tooth decay in young children. The trial enrolls 200 children starting at 2 to 6 months of age and follows them until around their fourth birthday. Families receive either fluoridated or non-fluoridated bottled water to use for drinking and food preparation. Dentists then count decayed, missing, or filled tooth surfaces to compare cavity rates between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluoridated bottled drinking water
- What this could lead to
- If fluoridated bottled water prevents cavities, it could offer a simple way to protect children's teeth in places without community water fluoridation.
- What could go wrong
- This early-stage trial may not show a clear benefit, and results in bottled water may not apply to all children or settings. Too much fluoride can cause faint white spots on teeth.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 6 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Division of Pediatric and Public Health, UNC Adams School of Dentistry
Chapel Hill, North Carolina, 27599-7455, United States
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Other studies related to the condition(s) this trial covers.
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