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New gel offers hope for chronic mouth burning

NCT ID NCT07214181

Symptom relief Sponsor: Universidad de Murcia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a gel containing amitriptyline, applied inside the mouth, could reduce pain in people with burning mouth syndrome. Researchers reviewed records of 30 adults who used the gel for several weeks. They measured pain levels before and after treatment and noted any side effects. The goal was to see if this gel is a safe and effective option for easing this chronic condition.

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.

Participants

30 people

The number who actually took part.

Started

Jan 2024

Finished

May 2025

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.

Who is studied

This retrospective study included adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria. All patients received topical amitriptyline 1% gel as part of routine clinical care and had complete medical records with baseline and 4-week follow-up data available for analysis.

Ages

18 years and older

Sex

Anyone

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: * Adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria (ICHD-3 and ICOP). Symptoms recurring daily for \>50% of the day for at least 3 months. Pain intensity ≥4 on a 0-10 numerical rating scale (NRS) at baseline. Normal appearance of the oral mucosa and normal intraoral clinical examination. Received topical amitriptyline 1% gel as part of routine care. Exclusion Criteria: * Missing or incomplete medical records.Use of other concomitant topical treatments on the oral mucosa during the study period. * Change in systemic pain medication while using topical amitriptyline gel. * Presence of local conditions and sytemic that could cause burning mouth symptoms (e.g., candidiasis, lichen planus, allergies, ).

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Conditions

The condition(s) this trial relates to.

burning mouth syndrome Pain Stomatodynia

As listed by the trial registrant

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

Burning mouth syndrome Stomatodynia

Contacts and locations

Locations

  • Clinica Odontologica Universitaria

    Murcia, Murcia, 30008, Spain

More trials for these conditions

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