Evaluating outcomes of facial reanimation surgery for facial paralysis
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation
This study is testing how well facial reanimation surgery helps people with one-sided facial paralysis feel and look better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04934176 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the outcomes of facial reanimation surgeries in patients with unilateral facial paralysis. Participants will undergo a free gracilis muscle transfer and will be evaluated using 3D analysis to measure facial disability and self-perception of facial appearance and well-being. The study will track patients at three time points: before surgery, and at five and eighteen months post-surgery, to capture the regenerative process and overall satisfaction. The research will focus on various surgical techniques and their impact on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unilateral facial paralysis scheduled for smile reconstruction surgery.
Not a fit: Patients with major facial deformities or conditions affecting facial movement due to primary muscular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of surgical outcomes and improve patient satisfaction and quality of life for those with facial paralysis.
How similar studies have performed: While there have been studies on facial reanimation, this specific approach focusing on 3D analysis and patient-centered outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- The Ohio State University College of Dentistry — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Carroll Ann Trotman, BDS, MA, MS — Ohio State University College of Dentistry
- Study coordinator: Carroll Ann Trotman, BDS, MA, MS
- Email: trotman.13@osu.edu
- Phone: 614-292-9755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.