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NCT04934176 · ClinicalTrials.gov registry record
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
A clinical trial of Facial Paralysis, sponsored by Tufts University.
- Recruiting
- Registry status
- 125
- Enrollment target
- 1
- Study location
NCT04934176: Recruiting study of Facial Paralysis, sponsored by Tufts University.
NCT04934176 is a study of Facial Paralysis that is actively recruiting participants, run by Tufts University. The registered enrollment target is 125 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04934176, a study of Facial Paralysis, is actively recruiting participants, sponsored by Tufts University.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
3D static facial photographs
Conditions Studied
Interventions
- OTHER Psychosocial scales/questionnaires
- OTHER 3D Facial Measurements
Study Locations (1)
Ohio
- The Ohio State University College of Dentistry - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2026-06-03 |
What NCT04934176 shows while recruiting
NCT04934176 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Facial Paralysis appearing as the primary indexed condition, and to 2 interventions - of which Psychosocial scales/questionnaires is the first listed.
NCT04934176 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04934176 about?
NCT04934176 is a clinical study titled "3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis". 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 c...
What is the current status of trial NCT04934176?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2021-06-03. Estimated completion is 2026-06-03.
What conditions does trial NCT04934176 study?
This clinical trial studies the following conditions: Facial Paralysis.
What interventions are being tested in trial NCT04934176?
The interventions under investigation include: Psychosocial scales/questionnaires (OTHER), 3D Facial Measurements (OTHER).
Who is sponsoring clinical trial NCT04934176?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04934176 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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