Tools for Return of Facial Function
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-100
SponsorThe University of Texas Medical Branch, Galveston
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Intraoral Stretching Splints
DeviceA 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Intraoral Splint TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
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 83
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 84
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 8Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: