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Observational Study of Facial Reanimation Surgery for Facial Paralysis

This study is looking at how well facial reanimation surgery works for people with facial paralysis. Researchers will use 3D measurements of your face and ask you to complete questionnaires to understand how the surgery affects your facial movement, appearance, and overall well-being. The study will focus on patients aged 18 to 75 who are having smile reconstruction surgery using a free gracilis muscle transfer (a type of muscle transplant) with different nerve connections. The main goal is to see how much facial impairment and disfigurement improve 18 months after surgery. This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment.

Study design
This is an observational study involving 125 participants. It is not a randomized or blinded study, meaning participants will know what treatment they are receiving.
What's involved
You would have 3D facial measurements, static 3D photographs, and video data collected at baseline (before surgery), and then at 5 and 18 months after surgery. You will also complete psychosocial questionnaires at baseline and 18 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 18 months after surgery to assess facial impairment and disfigurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04934176

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

Recruiting
Not specifiedAges 18–75Observational
Tufts University
~125 participants
Updated 2024-12-27 on ClinicalTrials.gov
What's tested:Psychosocial scales/questionnaires3D Facial Measurements

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Facial impairment and disfigurement
Measured over 18 months
+5 more outcomes measured

Conditions

Facial Paralysis

Explore related trials

Facial Nerve Paralysis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Carroll Ann Trotman, BDS, MA, MS · PRINCIPAL_INVESTIGATOR · Ohio State University College of Dentistry

Who to contact

Carroll Ann Trotman, BDS, MA, MS
[email protected]
614-292-9755
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Facial impairment and disfigurement18 months

    3D static facial photographs

  • Facial impairment and disfigurement18 months

    Video data of different facial animations

  • Facial impairment and disfigurement18 months

    3D objective facial movements/animations

  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis18 months

    Patient-centered questionnaires to assess condition-specific and general QOL. • The Facial Clinimetric Evaluation Scale (FaCE) covers six independent domains (facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function) over the course of 15 asked items. You will be asked to respond to questions around facial functionality on scales of 0 "No difficulty" to 2 "Both sides" and 1 "Not at all" to 5 "Normally"; how often facial paralysis impacts your quality of life on a scale of 1 "All of the time" to 5 "None of the time"; how you agree with certain statements on a scale of 1 "Strongly agree" to 5 "Strongly disagree".

  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis18 months

    Patient-centered questionnaires to assess condition-specific and general QOL. • The SF 36 is a generic health status measure, designed to assess functional status and well-being. This survey is broken into 11 domains. You will also be asked to respond to questions around how you feel and how well you are able to do your usual activities using various scales.

  • Self-perceptions of facial appearance and well-being in patients who undergo facial reanimation surgery to address unilateral, mid-facial paralysis18 months

    Patient-centered questionnaires to assess condition-specific and general QOL. • The Recovery Perception survey (PSP) assess a subject's perception of recovery. PSP is assessed by four domains: symptom issues, social/self issues, general health issues, and dentofacial issues. The PSP is comprised of 25 items. You will respond to a series of questions regarding your facial paralysis along a 7-point scale of "No problem" to "Serious problem".