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New study seeks best remedy for chronic mouth burning

NCT ID NCT06040190

Symptom relief Sponsor: Federal University of Minas Gerais 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study compares four treatments—clonazepam, capsaicin, photobiomodulation (light therapy), and alpha-lipoic acid—against a placebo for burning mouth syndrome. Researchers will enroll 150 adults with daily oral burning for over 3 months. The goal is to see which approach best reduces pain and improves quality of life.

What this could mean

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

Active substance
clonazepam, capsaicin, photobiomodulation, alpha-lipoic acid
What this could lead to
If successful, this trial could identify which treatment best reduces burning mouth pain and improves daily life.
What could go wrong
This is a small, early-phase study with no guarantee that any treatment will work better than placebo. Results may not apply to everyone with burning mouth syndrome.

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

50 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2026

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 to 70 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: * burning mouth syndrome; * oral pain that recurs daily for \> 2 hours per day for \> 3 months; * pain with burning quality and felt superficially in the oral mucosa; * oral mucosa appears normal * oral clinical examination, including sensory tests, is normal; Exclusion Criteria: * pregnancy; * oral mucosal lesions; * systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid; * gastroesophageal reflux; * previous head and neck radiotherapy; * Sjogren's disease; * allergies; * candidiasis; * unstimulated saliva flow \< 0.25 ml/min and stimulated flow \< 1.0 ml/min will be excluded;

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Conditions

The condition(s) this trial relates to.

burning mouth syndrome

As listed by the trial registrant

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

Burning mouth syndrome

Contacts and locations

Locations

  • Federal university of minas gerais

    Belo Horizonte, Minas Gerais, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.