Tools for Return of Facial Function

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT07825844
Status
Not Yet Recruiting

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Conditions

  • Burn
  • Facial Scar Contracture
  • Facial Scarring
  • Facial Trauma
  • Orofacial Contracture

Eligibility Criteria

Sex
ALL
Age
7 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Intraoral Stretching Splints — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Dec 31, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intraoral Splint Therapy
    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.

Primary Outcome Measure

Change in Facial Landmark Excursion [ Time Frame: Baseline to Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Medical BranchGalvestonTexas77555-

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