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New peptide varnish could reverse white spots without drilling

NCT ID NCT07289932

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two different varnishes for treating white spot lesions, which are early signs of tooth decay common after braces. One varnish uses a self-assembling peptide to help rebuild enamel, while the other delivers calcium and phosphate. Thirty-eight people aged 15-25 will have each varnish applied to one side of their mouth, and the spots will be tracked for 9 months to see which works better.

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) varnish and tri-calcium phosphate varnish
What this could lead to
If it works, this could offer a better way to reverse early tooth decay without drilling or fillings.
What could go wrong
This is a small, early-stage trial with only 38 people, so results may not apply to everyone. The treatments are compared to each other, not to a placebo, so we won't know if either is better than doing nothing.

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

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

About 38 people

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

Started

Feb 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

15 to 25 years

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: \- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment. * Age 15 years and ≤ 25 years * Size and form of the carious lesions must both be fully visible, and accessible * Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study * Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian. * patients not on medication affecting their salivary flow and medically free (ASA class I). Exclusion Criteria: * Evidence of tooth erosion. * any form of fluoride application before the study treatment. * patients with hypoplastic enamel defects, multiple restorations on the facial surfaces. * High caries risk patients

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Conditions

The condition(s) this trial relates to.

enamel caries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

White spot lesions

How to take part

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  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.

    Open the record ↗

  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

  • Ain-Shams University

    Cairo, Egypt

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