Tools for Return of Facial Function

NCT07825844 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-0178
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Scarring; Facial Trauma; Burn; Orofacial Contracture; Facial Scar Contracture

Outcome Measures

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.

  Baseline to Week 8

Secondary Outcomes (4)

• Change in Vertical Range of Mouth Opening (VROM)

  Baseline to Week 8

• Change in Horizontal Range of Mouth Opening (HROM)

  Baseline to Week 8

• Change in Mouth Impairment and Disability Assessment (MIDA) Score

  Baseline and Week 8

• Change in CARe Burn Scale Score

  Baseline and Week 8

Study Arms (1)

Intraoral Splint Therapy

EXPERIMENTAL

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.

Device: Intraoral Stretching Splints

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.

Intraoral Splint Therapy

Eligibility Criteria

• Age: 7 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Kathleen Kerr, MS

CONTACT

409-772-2711; kmkerr@UTMB.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

US (1)