Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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.

More Facial Paralysis trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment125 (estimated)
SponsorTufts University
Academic / other
Locations1 site (Columbus, Ohio)
StatusRecruiting
StartedJune 3, 2021
Main results expectedJanuary 3, 2026
Study endsJune 3, 2026
Registry record updatedDecember 27, 2024
Trial IDNCT04934176 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.