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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The Ohio State University College of Dentistry

Columbus, Ohio, United States, 43210

3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis | DecenTrialz