Actively Recruiting
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Unilateral Facial Paralysis
Led by Tufts University · Updated on 2024-12-27
125
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
Tufts University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with unilateral facial paralysis who are undergoing facial reanimation surgery to improve facial function and appearance. The study aims to compare the effects of different types of free gracilis muscle transfer surgeries driven by various nerve inputs and midfacial modifications. The research focuses on measuring facial impairment, disfigurement, and patients' self-perceptions of their facial appearance and well-being over time using 3D analysis and validated questionnaires. Participants will receive one of four surgical treatments involving free gracilis muscle transfer with nerve inputs from the trigeminal nerve, cross-face nerve graft, dual innervation from both nerves, or midfacial modification techniques. The surgeries are performed by the same surgeon at a single treatment center. The study includes three visits: before surgery, and then at 5 and 18 months after surgery. During each visit, patients undergo detailed facial movement assessments using 3D dynamic and static facial imaging, video recordings of facial animations, and psychosocial questionnaires. Participants will complete psychosocial questionnaires to assess their perceptions of facial appearance and recovery at baseline and 18 months post-surgery. Facial movement data is collected using advanced 3D systems that track facial soft tissue movements during various facial expressions. Video recordings capture multiple angles of facial animations. The study monitors changes in facial disability and patient well-being over 18 months and compares these outcomes among the surgical groups and with historical controls. The total study duration for each participant is approximately 18 months.
CONDITIONS
Official Title
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unilateral facial paralysis scheduled for smile reconstruction using free gracilis muscle transfer driven by trigeminal nerve (nV), cross-face nerve graft (nVII), dual innervation combining both nerves, or midfacial modifications
- Patient or parent interest and willingness to participate in the study
- Ability to understand verbal instructions
- Age between 18 and 75 years
You will not qualify if you...
- Major facial deformity or condition, congenital or acquired, such as hemifacial microsomia or cancer
- Facial movement disorders caused by primary muscle dysfunction or hemifacial spasm without synkinesis
- Mental or hearing impairments that limit comprehension or ability to complete tests
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University College of Dentistry
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
C
Carroll Ann Trotman, BDS, MA, MS
T
Tina Adathakkar
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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