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Search / Trial NCT04934176

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

Launched by TUFTS UNIVERSITY · Jun 16, 2021

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how different types of facial reanimation surgeries can help people with facial paralysis feel better about their appearance and improve their quality of life. The researchers want to find out how effective these surgeries are by comparing the facial function and personal satisfaction of patients who have undergone surgery. They will look at four different surgical methods and assess changes in facial movement and self-perception before and after the procedures. The study will use advanced 3D technology to measure facial improvements more accurately.

To be eligible to participate, you should be between 18 to 68 years old and have a specific type of facial paralysis that requires smile reconstruction surgery. You’ll need to be able to understand verbal instructions and be willing to take part in the study. If you join, you can expect to undergo a thorough evaluation and follow-up assessments over time to see how the surgery has impacted your facial function and overall well-being. It's important to know that individuals with certain major facial conditions or movement disorders will not be eligible for this study.

Gender

ALL

Eligibility criteria

  • 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 Tufts University

Tufts University is a prestigious research institution renowned for its commitment to advancing health and medicine through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Tufts leverages its expertise in biomedical research, public health, and clinical practice to design and conduct rigorous studies that address critical health challenges. The university's clinical trial programs are characterized by their adherence to high ethical standards and regulatory compliance, ensuring the safety and well-being of participants while contributing valuable insights to the scientific community. Through its dedication to fostering education and research, Tufts University plays a vital role in translating findings into effective health interventions and policies.

Locations

Boston, Massachusetts, United States

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Carroll Ann Trotman, BDS, MA, MS

Principal Investigator

Ohio State University College of Dentistry

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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