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3D-Printed mouth stretcher could help burn survivors eat and speak again

NCT ID NCT07264218

Symptom relief Sponsor: Hangang Sacred Heart Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a custom-made mouthpiece created with 3D scanning and printing for people whose mouths became tight after burn scars. Ten participants will wear the mouthpiece all day except during meals for two months. Researchers will measure if it improves mouth opening and scar appearance.

What this could mean

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

Active substance
patient-tailored 3D-printed mouthpiece
What this could lead to
If it works, this could offer a simple, custom way to stretch mouth scars and improve eating and speaking for burn survivors.
What could go wrong
This is a very small pilot study with only 10 people, so results may not apply to everyone. The mouthpiece must be worn all day, which may be uncomfortable, and it may not work for all scar types.

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 10 people

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

Started

Jul 2025

Expected to finish

Jan 2026

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: * who underwent skin grafting after suffering from deep second- or third degree burns around the mouth * who complained of difficulties in daily life such as difficulty in eating, pronunciation, and oral hygine care due to microstomia Exclusion Criteria: * diagnosed with limited temporomandibular joint movement after or before burn injury * at risk of skin damage when wearing an open mouthpiece * with bleeding at the scar site or scar at risk of epidermal damage * with peripheral vascular diseases with reduced blood circulation * who withdrew consent.

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Conditions

The condition(s) this trial relates to.

burn Microstomia

As listed by the trial registrant

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

3D printing Burn Microstomia Split thickness skin graft

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hangang Scared Heart Hospital IRB

    Seoul, 07247, South Korea

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