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Tooth enamel regrown with a gel? a new trial explores a drill-free fix for early decay.

NCT ID NCT07730359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This pilot trial tests a gel called Epinamel that aims to regrow tooth enamel naturally by using minerals from saliva. It includes 20 people who just had their braces removed and have white spot lesions—early signs of decay—on both sides of their mouth. The gel is applied to one side, while a standard treatment is used on the other, to see which works better at shrinking or reversing the lesions.

What this could mean

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

Active substance
a gel that rebuilds tooth enamel by trapping calcium and phosphate from saliva
What this could lead to
If it works, this could offer a simple, natural-looking way to repair early tooth decay without drilling or fillings.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply widely. The gel is new and unproven compared to existing treatments.

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 20 people

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

Started

Jul 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

12 to 60 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: * • Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation * Have at least one active non-cavitated carious lesions around the bracket area with a rough, chalky and matte surface (white spot lesions - WSLs) at each side of the mouth; * Have carious lesion which are fully visible, assessable and accessible; * Are able and willing to observe good oral hygiene throughout the study; * Have ≥20 teeth and a BPE score of \<3; * Have completed fixed orthodontic treatment within the past 24-120 hours. * Are aged 12-60 years * Are willing and able to attend the on-study visits; * Are willing and able to understand all study-related procedures; * Provide written informed consent (by parent/guardian if minor) before participation in the study. * No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process. Exclusion Criteria: * • Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients. * Patients with severe pulpitis or oral infections * Patients who are still be undergoing treatment using dental braces or brackets at time of study initiation * Patients who are vulnerable * Patients who are participating in another trial * Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia * Participants who had evidence of reduced salivary flow, systemic, or medical complications * Participants with cavitated lesions

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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.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London

    RECRUITING

    London, SE1 9RT, United Kingdom

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