Evaluating outcomes of facial reanimation surgery for facial paralysis
Official title: 3D Dynamic and Patient-Centered Outcomes of Facial Reanimation
Run by Tufts University · NCT04934176 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 125 (estimated) |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | June 3, 2021 |
| Main results expected | January 3, 2026 |
| Study ends | June 3, 2026 |
| Registry record updated | December 27, 2024 |
| Trial ID | NCT04934176 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with unilateral facial paralysis scheduled for smile reconstruction surgery.
✕Probably not a fit
Patients with major facial deformities or conditions affecting facial movement due to primary muscular dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on facial reanimation, this specific approach focusing on 3D analysis and patient-centered outcomes is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combined neural mobilization with proprioceptive therapy for Bell’s palsy facial symmetry
A randomized trial tests whether adding neural mobilization to proprioceptive neuromuscular facilitation helps improve facial symmetry in people with Bell’s palsy.
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Using electrical stimulation during surgery to improve facial nerve graft outcomes
This study is testing if using electrical stimulation during surgery can help improve nerve healing and smiles for people getting surgery for facial paralysis.
-
3 Tesla MRI measurements of facial skin muscles in people with facial paralysis
This will use a 3 Tesla MRI to see if measuring facial muscle thickness and volume helps understand muscle loss and guide care for adults with facial paralysis.
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Intradermal acupuncture for ocular surface problems after intractable facial paralysis
This study will test whether tiny needles placed just under the skin can improve dry eye and other ocular surface symptoms in adults with persistent peripheral facial paralysis.
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Exploring the link between facial paralysis and homocysteine levels
This study looks at whether higher levels of a substance in the blood called homocysteine are linked to Bell's palsy in adults who suddenly experience facial weakness or paralysis.
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Evaluating Korean medicine for treating Bell's palsy
This study is testing if Korean medicine can help adults with Bell's palsy improve their facial function and overall condition over three months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.