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Not Yet Recruiting NCT07825844

Tools for Return of Facial Function

Conditions: Facial Scarring, Facial Trauma, Burn, Orofacial Contracture, Facial Scar Contracture

Sex: All
Ages: 7 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: The University of Texas Medical Branch, Galveston

Location: The University of Texas Medical Branch Galveston Texas

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07825844). StuddyBuddy aggregates publicly available trial information.