An interventional study of Intraoral Stretching Splints in Facial Scarring, Facial Trauma and Burn, sponsored by The University of Texas Medical Branch, Galveston. Not yet recruiting at 1 site in United States. Open to participants aged 7 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
This study will evaluate novel intraoral (inside-the-mouth) splints designed to gently stretch facial tissues that have become tight or scarred following facial trauma, including burn injuries and gunshot wounds. Scar contractures can limit mouth opening, facial movement, and facial expressions, affecting daily function and quality of life.
Participants aged 7 years and older with facial contractures will be fitted with one or more silicone splints selected by a trained speech-language pathologist based on each participant's areas of restriction. The splints are available in different shapes and sizes and are designed to provide passive stretching to targeted areas of the face and mouth.
Researchers will assess changes in facial mobility, mouth opening, facial symmetry, and range of facial expression using clinical measurements and facial movement analysis software. The study will also help identify appropriate treatment protocols for use of the splints.
The researchers expect that use of the splints may improve facial movement and function, reduce the effects of scar contractures, and potentially decrease the need for future surgical procedures to improve facial mobility. Findings from this study may support a new treatment option for individuals with facial scarring due to burns or other traumatic injuries.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with facial burns or other facial trauma resulting in orofacial contractures, scarring, fibrosis, or limited facial movement will receive individualized treatment using intraoral stretching splints. A trained speech-language pathologist will select the appropriate splint shape, size, and placement based on each participant's areas of facial restriction. Participants will use the prescribed splint or splints twice daily for approximately 60 minutes per session over an 8-week treatment period, with weekly assessments and adjustment of the treatment plan as needed.
Device: Intraoral Stretching Splints
A set of three silicone intraoral splints (ball, bar, and boomerang shapes) designed to provide passive stretching of scarred or contracted orofacial tissues. Splints are available in multiple sizes and may be used unilaterally or bilaterally to target specific areas of facial tightness and restricted movement.
Change in Facial Landmark Excursion
Change from baseline in excursion (millimeters) between predefined facial landmarks during standardized facial expressions (rest, nose wrinkle, broad smile, lip pucker, and maximum mouth opening), measured using customized facial measurement software.
Time frame: Baseline to Week 8
Change in Vertical Range of Mouth Opening (VROM)
Change from baseline in maximum vertical mouth opening measured in millimeters using a digital caliper.
Time frame: Baseline to Week 8
Change in Horizontal Range of Mouth Opening (HROM)
Change from baseline in maximum horizontal mouth opening measured in millimeters using a digital caliper.
Time frame: Baseline to Week 8
Change in Mouth Impairment and Disability Assessment (MIDA) Score
Change from baseline in functional impairment and disability related to oral function as measured by the Mouth Impairment and Disability Assessment (MIDA). The MIDA includes patient-reported and clinician-assessed measures of symptoms, impairment, and functional activities.
Time frame: Baseline and Week 8
Change in CARe Burn Scale Score
Change from baseline in burn-specific quality of life as measured by the age-appropriate CARe Burn Scale questionnaire.
Time frame: Baseline and Week 8
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 15 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Medical Branch, Galveston →