Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury

January 4, 2020 updated by: Ahmed Mohamed Basem

Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons

Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Recruiting
        • Faculty of Oral and Dental Medicine Cairo University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

5 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with hemimandiblectomy
  • Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months
  • Age group : from 15 to 60 years old
  • No sex predilection
  • Patients with no contraindications to surgical intervention

Exclusion Criteria:

  • • Patients with systemic condition counteracting with the surgical procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient lost sensation ant half of lower lip
patient with injured inferior alveolar nerve at one side
-sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Time Frame: 1 year
The primary outcome is restoration of sensation of lower lip and chin sensation determined by Two discrimination point test at 6 months . Aggregation will be done by percentage/ratio of successful cases number in the study. Calculation of the mean of all cases will be performed for analysis of the results.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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