3D Dynamic and Patient-Centered Outcomes of Facial Reanimation

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
The Ohio State University College of Dentistry
RECRUITING
Columbus
Contact Information
Primary
Carroll Ann Trotman, BDS, MA, MS
trotman.13@osu.edu
614-292-9755
Backup
Tina Adathakkar
adathakkar.1@osu.edu
614-366-5571
Time Frame
Start Date: 2021-06-03
Estimated Completion Date: 2026-06-03
Participants
Target number of participants: 125
Treatments
Group 1
Group 1 will have had a muscle transfer driven by the trigeminal nerve (nV).
Group 2
Group 2 will have had a muscle transfer driven by a cross-face nerve graft (nVII).
Group 3
Group 3 will have had a muscle transfer driven by dual innervation using both the trigeminal and cross-face nerve graft.
Group 4
Group 4 will have had manipulations 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.
Related Therapeutic Areas
Sponsors
Leads: Tufts University
Collaborators: National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov