Actively Recruiting
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
Led by Tufts University · Updated on 2024-12-27
125
Participants Needed
1
Research Sites
21 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 evaluating outcomes of facial reanimation surgeries in patients with extensive, permanent, unilateral mid-facial paralysis from various causes. The study aims to compare facial disability and patient perceptions of facial appearance, well-being, and satisfaction among four groups undergoing different types of free gracilis muscle transfer surgeries. The investigation also compares surgeons' assessments with objective 3D analyses to determine the usefulness of 3D measures as outcome tools. This prospective observational study includes patients aged 18 to 75 scheduled for facial muscle reconstruction with one of four nerve innervation methods: trigeminal nerve graft, cross-face nerve graft, dual innervation, or midfacial modification involving nerve coaptation and selective neurolysis. Participants will be recruited from a single treatment center and followed at three visits: before surgery, and at 5 and 18 months after surgery to track changes in facial movement and patient well-being. At each visit, patients complete psychosocial questionnaires assessing the impact of paralysis and recovery, undergo 3D dynamic facial movement recordings, static 3D facial photography, and video recordings of facial animations. Data collected include facial impairment and disfigurement measures, patient-centered quality of life questionnaires, and comparisons of clinical scoring with 3D objective assessments. The total study duration for each participant is 18 months, focusing on long-term surgical outcomes.
CONDITIONS
Brief 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 with one of four nerve inputs: trigeminal nerve (nV), cross-face nerve graft (nVII), dual innervation, or midfacial modification
- 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 muscular dysfunction or hemifacial spasm without synkinesis
- Mental or hearing impairments limiting comprehension or ability to perform tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete psychosocial questionnaires and undergo 3D dynamic facial movement data collection, static 3D facial photography, and video recording of facial animations before surgery.
1 baseline visit (in-person) before surgery
Duration - Surgery day
Participants undergo facial muscle reconstruction surgery using free gracilis muscle transfer with one of four nerve innervations to address unilateral, mid-facial paralysis.
1 surgery day
Duration - 18 months post-surgery
Participants return for follow-up visits at 5 and 18 months after surgery for repeat psychosocial questionnaires (at 18 months) and repeated 3D dynamic facial movement data collection, static 3D facial photography, and video recording to assess facial function and patient perceptions.
2 visits (at 5 and 18 months post-surgery, in-person)
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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