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Could a skin needling tool and plant extract lighten dark gums?

NCT ID NCT07410156

Symptom relief Sponsor: Fayoum University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new way to lighten dark gums using a microneedling pen and a cream made from milk thistle extract (silymarin). It compares this method to two standard treatments: cutting the dark tissue away with a scalpel or burning it off with a laser. Thirty adults with naturally dark gums will be randomly assigned to one of the three groups. The main goal is to see how well the pigmentation fades and whether it comes back.

What this could mean

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

Active substance
Silymarin (topical cream)
What this could lead to
If it works, this could offer a less painful, effective option for reducing dark gums without cutting or lasers.
What could go wrong
This is a small, early-stage trial with only 30 people. The results may not apply to everyone, and the treatment might not work better than existing methods.

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 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

18 years and older

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: 1. Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index 2. Patient with physiologic pigmentation 3. Non smoker 4. Patient agree to sign the written consent 5. Both genders Exclusion Criteria: 1. Pregnant and lactating women 2. Systemic conditions affect melanin production 3. Medications induce pigmentation or enlargement 4. Those with known allergies to silymarin.

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As listed by the trial registrant

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

Gingival hyperpigmentaion Gingival pigmentation

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

  • Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology

    RECRUITING

    Al Fayyum, Egypt

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