Status:
RECRUITING
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Facial Paralysis
Eligibility:
All Genders
18-75 years
Brief Summary
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 reanimati...
Detailed Description
This, prospective, observational study has two goals which are to determine outcomes of (1) facial impairment and disfigurement, and (2) self-perceptions of facial appearance and well-being in patient...
Eligibility Criteria
Inclusion Criteria:
- Patients with unilateral facial paralysis scheduled for smile reconstruction using free gracilis muscle transfer driven by one of four neuronal inputs, specifically, the trigeminal nerve (nV), a cross-face nerve graft (nVII), dual innervation combining the trigeminal nerve, a cross face nerve graft, and patients who have midfacial modifications that involve performing direct coaptation between the trigeminal nerve and a branch to the native zygomaticus major muscle (5-7 transfer) and selective neurolysis in which several facial nerve branches that innervate muscles antagonistic to the smile animation are transected.
- Patient/parent interest/willingness to participate in the study
- An ability to comprehend verbal instructions
- An age range of 18 to 75 years
Exclusion Criteria:
- Presence of a major facial deformity/condition either congenital or acquired e.g. hemifacial microsomia, cancer
- Facial movement disorders due to primary muscular dysfunction or hemifacial spasm in the absence of synkinesis
- Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered
Key Trial Info
Start Date :
June 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 3 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04934176
Start Date
June 3 2021
End Date
June 3 2026
Last Update
December 27 2024
Active Locations (1)
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1
The Ohio State University College of Dentistry
Columbus, Ohio, United States, 43210