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New mouthwash aims to soothe chronic mouth burning

NCT ID NCT07506018

Symptom relief Sponsor: Baptist Health South Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests a mouth rinse called MucoLock for people with ongoing mouth pain or burning sensation (stomatitis). About 25 adults will swish the rinse for 5 minutes, three times a day, for 28 days. Researchers will measure changes in pain scores and quality of life to see if the rinse is tolerable and effective.

What this could mean

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

Active substance
MucoLock oral rinse (a medical device used as a mouthwash)
What this could lead to
If it works, this could offer a simple, non-drug mouth rinse to ease chronic mouth pain or burning sensation.
What could go wrong
This is a small, early-phase trial with only 25 people, so results may not apply to everyone. It tests symptom relief, not a cure, and some may not respond.

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 25 people

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

Started

Jul 2026

Expected to finish

Aug 2028

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

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: * Age 18 years and older * Individuals with oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Inability to comply with study instructions * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements\* * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. * Advanced kidney disease * Patients receiving antineoplastic therapy \[e.g., tyrosine kinase inhibitors (TKIs), radiation\] that could increase the risk of oral dysesthesia * Known altered mental status, encephalopathy, or cognition impairment * Ataxia * Known alcohol use disorder * Concomitant opioid therapy * Diagnosis of oral cancer currently undergoing therapy * Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)\* * Any opioid pain medication\* * Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment. (asterisk) \*Modifiable criteria, with a timeframe of 2 weeks for a washout period.

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Conditions

The condition(s) this trial relates to.

burning mouth syndrome Pain stomatitis

As listed by the trial registrant

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

Burning mouth Burning mouth syndrome Oral dysesthesia Pain Stomatitis

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

  • Miami Cancer Institute at Baptist Health, Inc.

    RECRUITING

    Miami, Florida, 33176, United States

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