Burn, Facial Scar Contracture, Facial Scarring, Facial Trauma, Orofacial Contracture
Conditions
Brief summary
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.
Interventions
DEVICEIntraoral 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Landmark Excursion | Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vertical Range of Mouth Opening (VROM) | Baseline to Week 8 | Change from baseline in maximum vertical mouth opening measured in millimeters using a digital caliper. |
| Change in Horizontal Range of Mouth Opening (HROM) | Baseline to Week 8 | Change from baseline in maximum horizontal mouth opening measured in millimeters using a digital caliper. |
| Change in Mouth Impairment and Disability Assessment (MIDA) Score | Baseline and Week 8 | 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. |
| Change in CARe Burn Scale Score | Baseline and Week 8 | Change from baseline in burn-specific quality of life as measured by the age-appropriate CARe Burn Scale questionnaire. |
Countries
United States
Contacts
CONTACTKathleen Kerr, MS
Outcome results
None listed