New study aims to stop cavities in kids with simple, painless treatments
NCT ID NCT06999005
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test whether applying fluoride varnish and placing special sealants can prevent and control cavities in 2,500 children aged 6 to 12. The treatments are minimally invasive and designed for use in public health settings. Children will be checked every three months for two years to see if their cavities stop getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluoride varnish and glass ionomer cement sealants
- What this could lead to
- If successful, this could provide an effective, low-cost cavity prevention program for schoolchildren that can be used in public health systems.
- What could go wrong
- This is a large but early-stage study without a control group, so results may not prove the treatments are better than standard care. Also, children may miss follow-up visits, affecting outcomes.
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
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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 2,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
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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6 to 12 years
- 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: * Children aged between 6 and 12 years at the time of enrollment * Presence of at least one erupted permanent first molar * Diagnosis of active caries lesions classified according to ICDAS (scores 1 to 6) * Written informed consent signed by a legal guardian and assent signed by the child * Ability to attend quarterly follow-up visits over a 24-month period Exclusion Criteria: * Children requiring endodontic treatment or presenting extensive pulpal involvement * Presence of systemic diseases or medical conditions that contraindicate dental care * Known allergy to any material used in the study (fluoride varnish, high-viscosity glass ionomer cement) * Participation in other clinical dental studies that could interfere with the outcomes
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universidade Metropolitana de Santos - UNIMES
RECRUITINGSantos, São Paulo, 11045-002, Brazil
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Other studies related to the condition(s) this trial covers.
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