Could a peptide gel make early cavities disappear?
NCT ID NCT07664046
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a self-assembling peptide called P11-4 can help remineralize white spot lesions—early signs of tooth decay—on smooth tooth surfaces. Seventy-five participants aged 10 to 17 will be split into three groups: one gets a single peptide application, another gets two applications three months apart, and a third gets standard fluoride varnish every three months. The main goal is to see if the peptide reduces the size and severity of the lesions over 12 months using a special fluorescence camera.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- self-assembling peptide P11-4
- What this could lead to
- If it works, this could offer a new, non-invasive way to reverse early tooth decay without drilling or fillings.
- What could go wrong
- This is a small, early-stage trial with only 75 participants. The peptide may not work better than standard fluoride varnish, and results may not apply to all ages or tooth types.
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 75 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 2027
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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10 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. Age \>10 years and \<18 years. 2. Presence of at least 2 active enamel carious white spot lesions on a smooth tooth surface (labial/buccal surfaces of permanent teeth) based on International Caries Detection (ICDAS II) and Assessment System -Lesion Activity Assessment (ICDAS-LAA), and Lesion Activity Assessment (LAA criteria). 3. Tooth eligible for treatment: 1. Vital pulp, 2. no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA\>7; 3. QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2), 4. no history of trauma to the tooth. 4. Systemically healthy patient. 5. No contraindications to the use of fluoride preparations. 6. No fixed orthodontic appliance. 7. Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient. Exclusion Criteria: 1. Systemic diseases or chronic medication use due to chronic conditions. 2. Viral/bacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction). 3. Pregnancy or breastfeeding. 4. Allergy to any component of the SAP P11-4 preparation or the fluoride varnish. 5. Professional fluoride prophylaxis performed \<3 months ago. 6. Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA\<7, LAA code 0, 2-9. 7. Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin). 8. Developmental enamel defects. 9. Patient undergoing orthodontic treatment with fixed appliances. 10. Inability to ensure regular follow-up visits. 11. Lack of cooperation from the guardian or the patient. 12. Refusal to participate in the study and/or absence of written consent.
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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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University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry
RECRUITINGWarsaw, Masovian Voivodeship, 02-097, Poland