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Silicone splints worn inside the mouth could loosen disfiguring facial scars

NCT ID NCT07825844

Symptom relief Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing custom silicone splints that fit inside the mouth to gently stretch facial tissue that has tightened or scarred after burns, trauma, or gunshot wounds. The study includes people aged 7 and older whose scars limit mouth opening, chewing, speaking, or facial expression. A speech-language pathologist fits each participant with one or more splints chosen for their specific areas of tightness. The team measures changes in mouth opening, facial symmetry, and facial movement to see whether the splints help and to work out the best way to use them.

What this could mean

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

Active substance
custom silicone intraoral stretching splints
What this could lead to
If the splints help, they could offer a non-surgical way to loosen tight facial scars and improve mouth opening and facial expression for people recovering from burns or facial trauma.
What could go wrong
This is a small study of 50 people, and stretching scar tissue takes time and daily commitment. Results may not apply to everyone, and some scars may still need surgery.

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 50 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

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

7 to 100 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: * Age 7-100 * Male or Female Sex * Patients who have sustained facial trauma, facial injury or a facial burn and are now in the chronic phase * Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or limited facial expressions * Subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent * Subject or caregiver (parent or guardian, in case of pediatric population) must be able to perform exercises at home and must be able to record time spent using the splints * Participants who are undergoing other treatment methods such as facial surgeries, use of compression garments, skin grafting, etc., must suspend all these treatments for the duration of the 8-week trial * Access to internet and smartphone or computer capable of taking screenshots and with adequate audio and video capabilities (for those opting to participate via telehealth sessions Exclusion Criteria: * Planned or unplanned surgeries for facial skin grafting around lips or nose, or oral commissure release during the 8-week trial * Completion of any massaging or other stretching exercises or programs not specified by the investigators * Use of new creams or topical treatments for the duration of enrollment in the study * Acutely burn-injured patients * Incarceration or pregnancy * History of neurological deficit

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Conditions

The condition(s) this trial relates to.

burn

As listed by the trial registrant

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

Burn Facial scar contracture Facial scarring Facial trauma Orofacial contracture

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • The University of Texas Medical Branch

    Galveston, Texas, 77555, United States

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