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
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
In this study, patients who have undergone facial paralysis surgery will be asked to participate. The goal of this study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. The focus point of this study will be on outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation. The specific aims of the study are as follows. Specific Aim 1. To quantitatively determine the surgical effects/impact on facial disability (facial impairment and disfigurement) among four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer driven by (1) a trigeminal nerve (nV) graft, (2) a crossface nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification. 1. We will compare the changes in facial disability among the groups before and after surgery, and the differences in facial disability between each surgery group and the controls before and after surgery. 2. Specific Aim 2. To compare among the surgery groups the changes in self-perceptions of facial appearance and well-being that occur due to facial reanimation surgery, and to compare the surgery groups before and at 18 months to historical controls recruited during the tenure of the R21 grant. 3. Specific Aim 3. In patients with facial paralysis, to compare surgeons' current qualitative assessment and 2D, quantitative assessment of facial impairment and disfigurement with the objective, 3D, quantitative assessments in order to determine the clinical utility of the 3D assessment approach as an outcome measure and relevance for dissemination to the surgical community.
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
CONTACT
T
Tina Adathakkar
CONTACT
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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