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Blue light, blue dye, brighter smiles: a new approach to stubborn tooth stains in children

NCT ID NCT07736339

Disease control Sponsor: Cairo 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This pilot trial tests whether adding antimicrobial photodynamic therapy (aPDT) with methylene blue to a standard dental cleaning can prevent chromogenic stains from returning on baby teeth. About 36 children aged 4 to 6 with these stains will receive either standard prophylaxis alone or standard prophylaxis followed by a topical application of methylene blue activated by a red laser. The study will compare stain recurrence over six months.

What this could mean

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

Active substance
antimicrobial photodynamic therapy using methylene blue activated by red light
What this could lead to
If it works, this could offer a simple, non-invasive way to keep children's teeth stain-free longer after a dental cleaning.
What could go wrong
This is a small pilot study, so results may not apply broadly. Methylene blue can cause temporary blue discoloration of teeth and soft tissues, and some children may have an allergic reaction.

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 36 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

Jul 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

4 to 6 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: * Children aged 4 to 6 years with chromogenic extrinsic stains affecting deciduous teeth. * Medically healthy children (ASA I or II). * Children with cooperative behavior suitable for routine dental treatment. * Parent or legal guardian willing to provide written informed consent. * Ability to attend all scheduled follow-up visits. Exclusion Criteria: * Known allergy or hypersensitivity to methylene blue. * Photosensitivity disorders or current use of photosensitizing medications. * Extensive untreated dental caries or acute dental infection requiring emergency treatment. * Gingival or periodontal conditions that interfere with clinical assessment. * Iron-associated extrinsic staining. * Children unable to comply with study procedures or follow-up visits.

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As listed by the trial registrant

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

Chromogenic extrinsic tooth stains

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

  • Cairo University

    Cairo, Cairo Governorate, Egypt