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Could a simple mouthwash soothe chronic mouth pain?

NCT ID NCT07280442

Symptom relief Sponsor: Universidad Complutense de Madrid 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a mouthwash containing sodium hyaluronate and Sh-Oligopeptide-85 can reduce pain and sores in people with oral lichen planus, a chronic inflammatory condition. Forty adults with painful mouth lesions will use either the test mouthwash or a standard corticosteroid mouthwash for four weeks. Researchers will measure changes in pain and lesion severity to see if the new option works as well as steroids.

What this could mean

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

Active substance
sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP mouthwash
What this could lead to
If it works, this mouthwash could offer a gentler option to reduce pain and sores from oral lichen planus without using steroids.
What could go wrong
This is a small, early-phase trial with only 40 people, so results may not apply to everyone. The mouthwash may not improve symptoms, and individual responses vary.

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

About 40 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

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.

Patients must meet the following inclusion criteria: 1. Patients aged ≥18 years. 2. Patients with a clinical and histological diagnosis of OLP according to the criteria of the American Academy of Oral and Maxillofacial Pathology (Cheng et al., 2016). 3. Symptomatic patients, i.e., those presenting atrophic-erosive or ulcerative OLP lesions. 4. Patients with a VAS score ≤ 6. Exclusion criteria will be: 1. Pregnant or breastfeeding women. 2. Allergy to the components of the Tectum-11® mouthwash. 3. Patients receiving corticosteroids, immunosuppressants, hydroxychloroquine, or retinoids at the time of recruitment. 4. Patients with lichenoid lesions: drug-induced lichenoid reactions, contact lichenoid lesions, or graft-versus-host disease. 5. Use of topical corticosteroids within the previous 4 weeks or systemic treatment within the previous 8 weeks. 6. Use of other mouthrinses for plaque control. 7. Patients unwilling to sign the informed consent form. 8. Patients with a VAS score \> 6. The presence of any of the following criteria will lead to withdrawal of the participant from the study: 1. Failure to attend follow-up visits. 2. Occurrence of adverse events deemed clinically relevant by the investigator. 3. The patient reports that they no longer wish to participate in the study. 4. Development of oral or systemic lesions that meet any of the exclusion criteria. 5. Non-adherence to the treatment regimen, defined as failure to follow the protocol for more than two consecutive weeks.

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Conditions

The condition(s) this trial relates to.

lichen planus, oral

As listed by the trial registrant

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

Oral lichen planus

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

  • Departamento de Especialidades Clínicas Odonotlógicas, Facultad de Odontología, Universidad Complutense de Madrid

    Madrid, 28040, Spain

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