RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

3D Dynamic and Patient-Centered Outcomes of Facial Reanimation

Quick Facts

Study Start:2021-06-03
Study Completion:2024-06-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04934176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 68 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patient/parent interest/willingness to participate in the study
  3. * An ability to comprehend verbal instructions
  4. * An age range of 18 to 68 years
  1. * Presence of a major facial deformity/condition either congenital or acquired e.g. hemifacial microsomia, cancer
  2. * Facial movement disorders due to primary muscular dysfunction or hemifacial spasm in the absence of synkinesis
  3. * Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered

Contacts and Locations

Study Contact

Carroll Ann Trotman, BDS, MA, MS
CONTACT
(617) 636-0846
Carroll_Ann.Trotman@tufts.edu
Gerard Kugel, DMD, MS, PhD
CONTACT
617-636-3865
dentalresearchadministration@tufts.edu

Principal Investigator

Carroll Ann Trotman, BDS, MA, MS
PRINCIPAL_INVESTIGATOR
TUSDM

Study Locations (Sites)

Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts University

  • Carroll Ann Trotman, BDS, MA, MS, PRINCIPAL_INVESTIGATOR, TUSDM

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-03
Study Completion Date2024-06-03

Study Record Updates

Study Start Date2021-06-03
Study Completion Date2024-06-03

Terms related to this study

Additional Relevant MeSH Terms

  • Facial Paralysis