Tools for Return of Facial Function
Translating Science Into Tools for Return of Facial Function
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathleen Kerr, MS
- Phone Number: 409-772-2711
- Email: kmkerr@UTMB.EDU
Study Locations
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-
Texas
-
Galveston, Texas, United States, 77555
- The University of Texas Medical Branch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Facial Landmark Excursion
Time Frame: 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.
|
Baseline to Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Vertical Range of Mouth Opening (VROM)
Time Frame: Baseline to Week 8
|
Change from baseline in maximum vertical mouth opening measured in millimeters using a digital caliper.
|
Baseline to Week 8
|
|
Change in Horizontal Range of Mouth Opening (HROM)
Time Frame: Baseline to Week 8
|
Change from baseline in maximum horizontal mouth opening measured in millimeters using a digital caliper.
|
Baseline to Week 8
|
|
Change in Mouth Impairment and Disability Assessment (MIDA) Score
Time Frame: 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.
|
Baseline and Week 8
|
|
Change in CARe Burn Scale Score
Time Frame: Baseline and Week 8
|
Change from baseline in burn-specific quality of life as measured by the age-appropriate CARe Burn Scale questionnaire.
|
Baseline and Week 8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-0178
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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