New varnish could stop cavities before they start in young children

NCT ID NCT04947527

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested a special varnish painted on teeth to prevent cavities in 274 children aged 6 to 24 months. The varnish was compared to a standard fluoride varnish to see if it better prevented tooth decay. Researchers also checked for any side effects. The goal is to give young kids a simple, painless way to keep their teeth healthy.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

274 people

The number who actually took part.

Started

Jun 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 20 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: 1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form). 2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements. 3. The subject is a 6-24 months at the time of enrollment. 4. The subject must be in good general health as evidenced by parent report. 5. The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion. Exclusion Criteria: 1. Previous treatment with fluoride varnish 2. Known allergy to iodine 3. Diagnosis of thyroid disease 4. Chronic, prophylactic use of antibiotics 5. Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit. 6. Visible cavities (d2-4) 7. Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared) 8. Parent anticipates the child will move from Pohnpei during the next 2 years.

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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

  • Pohnpei State Hospital

    Pohnpei, FSM, 96941, United States Minor Outlying Islands

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Other studies related to the condition(s) this trial covers.