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Bottled water with fluoride put to the test against childhood cavities

NCT ID NCT04893681

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

2 to 6 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.