- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218474
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
Status
Unknown
Conditions
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
-
-
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Cairo, Egypt
- Recruiting
- Faculty of Oral and Dental Medicine Cairo University
-
Contact:
- ahmed basem
- Phone Number: asdsa 00201159300386
- Email: ahmed_basem1234@hotmail.com
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-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2569369
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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