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Can a peptide gel harden early cavities before they need drilling?

NCT ID NCT07829328

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a topical gel made of self-assembling P11-4 peptides and 0.05% sodium fluoride can make early cavities between teeth denser and stop them from progressing. The trial enrolls 30 active-duty military members who have small, non-cavitated lesions visible on X-rays. Participants receive one application of the gel plus standard brushing and flossing coaching, then get follow-up bitewing X-rays at 1 week, 1 month, and later visits to measure changes in lesion density.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A topical gel containing 0.05% sodium fluoride and self-assembling P11-4 peptides, applied directly to early cavities between teeth
What this could lead to
If it works, this could offer a needle-free way to stop early cavities between teeth from growing into holes that need drilling, and it could become a standard option for military dental care.
What could go wrong
This is a small Phase 4 study of 30 people, so the results may not hold up in larger groups or in civilians. The peptide gel may not harden the lesions enough to show up clearly on X-rays, and everyone in the study also gets brushing and flossing coaching, which makes it hard to tell how much the gel itself helps.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Active Duty military * must have 1 or more incipient, non-cavitated, interproximal carious lesions (E1, E2, or D1 in radiographic depth) * must have time remaining on post for at least 4 months from the start of treatment/enrollment Exclusion Criteria: * non-active duty military * interproximal carious lesions that are cavitated or D2-D3 in radiographic depth * tobacco, nicotine, and e-cigarette use

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. 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

  • Schofield Barracks Dental Clinic

    Schofield Barracks, Hawaii, 96857, United States