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3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
NCT04934176 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04934176
The ClinicalTrials.gov registry entry for NCT04934176 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts University, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04934176 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04934176?
The interventions under investigation include: Psychosocial scales/questionnaires (OTHER), 3D Facial Measurements (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04934176?
This trial is sponsored by Tufts University, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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