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

3D Dynamic and Patient-Centered Outcomes of Facial Reanimation

Who can join

Ages 18 to 75 · All sexes

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

About the study

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 reanimation surgeries in patients with extensive and permanent, unilateral paralysis using 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. The focus point of this study will be on outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation.

The specific aims of the study are as follows. Specific Aim 1. To quantitatively determine the surgical effects/impact on facial disability (facial impairment and disfigurement) among four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer driven by (1) a trigeminal nerve (nV) graft, (2) a crossface nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification.

1. We will compare the changes in facial disability among the groups before and after surgery, and the differences in facial disability between each surgery group and the controls before and after surgery. 2. Specific Aim 2. To compare among the surgery groups the changes in self-perceptions of facial appearance and well-being that occur due to facial reanimation surgery, and to compare the surgery groups before and at 18 months to historical controls recruited during the tenure of the R21 grant. 3. Specific Aim 3. In patients with facial paralysis, to compare surgeons' current qualitative assessment and 2D, quantitative assessment of facial impairment and disfigurement with the objective, 3D, quantitative assessments in order to determine the clinical utility of the 3D assessment approach as an outcome measure and relevance for dissemination to the surgical community.

What is being tested

• Psychosocial scales/questionnaires (other)
• 3D Facial Measurements (other)

Sponsor: Tufts University · Participants: 125 · Started: Jun 3, 2021

Contact the study team

• Carroll Ann Trotman, BDS, MA, MS · Phone: 614-292-9755
• Tina Adathakkar · Phone: 614-366-5571

Official record on ClinicalTrials.gov — NCT04934176

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.