Using the Masseteric Nerve for Facial Nerve Reanimation

NCT05568108 | Unknown

• 1 other identifier: Masseteric for facial nerve
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The return of eyelid function and facial expression in Patients with facial nerve affection is very important for quality of life. Eyelid dysfunction leads to drying and ulceration of cornea which may lead to permanent vision loss. Facial paralysis is distinguished into two main groups according to the presence or absence of facial fibrillations at needle Electromyography. Recent paralysis, mainly lasting less than two years generally show these signs and are eligible for reactivation of facial nerve by anastomosing it to a donor one (early facial reanimation). The masseteric nerve (motor branch of trigeminal nerve ) is a reliable donor nerve on early facial reanimation So on this study we examine the advantages and disadvantages of using masseteric nerve to develop a protocol for use of facial reanimation and restoration of function on facial paresis.

Conditions

Facial Nerve Paresis

Outcome Measures

Primary Outcomes (1)

• Comparing the outcomes on EFACE score

  difference on the score

  up to one year

Secondary Outcomes (1)

• Effect of addition of contracted growth factor around the anastomosis

  up to one year

Study Arms (2)

nerve transfer

masseteric nerve to central branch facial nerve. (Early fibrillation on EMG)

Procedure: masseteric nerve to central branch facial nerve

nerve and free functioning muscle transfer

Masseteric nerve to free functioning muscle transfer. (Late no fibrillation on EMG)

Procedure: Masseteric nerve to free functioning muscle transfer

Interventions

masseteric nerve to central branch facial nerve PROCEDURE

masseteric nerve to central branch facial nerve. (Early fibrillation on EMG)

nerve transfer

Masseteric nerve to free functioning muscle transfer PROCEDURE

Masseteric nerve to free functioning muscle transfer. (Late no fibrillation on EMG)

nerve and free functioning muscle transfer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Facial nerve affection patients

You may qualify if:

• Facial nerve affection
• Patients are generally fit with no other disease interfere with microsurgery.
• Electromyography showing fibrillations for group A and no fibrillation for group B.

You may not qualify if:

• Patient with other medical or mental disease-causing generalized paralysis.
• Syndromic cases.
• Patients are generally unfit or with any disease interfere with microsurgery.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Plastic Surgery Department Assiut University

Asyut, 71511, Egypt

RECRUITING

Study Officials

• Ahmed M refaat, mcch

  faculty of medcine assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M refaat, MCCh

CONTACT

00201008022747; ahmed.abdelkarim@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assitant lecturer of plastic and reconstructive surgery

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: November 4, 2020
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

EG (1)