Intraoral Stretching Splints for Facial Scarring
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people aged 7 and older who have tightness or scarring in the face or mouth that limits movement, often due to injuries like burns, fractures, or surgery. Participants must have facial contractures affecting their ability to open their mouth or move their face.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Intraoral Stretching Splints
Trial Overview
The study tests custom-made silicone splints worn inside the mouth to gently stretch tight facial tissues. Researchers will measure changes in how well participants can move their faces and open their mouths after using these splints.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
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