New varnish could stop cavities before they start in young children
NCT ID NCT04947527
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.
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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
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274 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
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Aug 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
-
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: 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.
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