Back to resultsEvaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Primary Purpose
Injury of Mental Nerve of One Side
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Sponsored by
About this trial
This is an interventional treatment trial for Injury of Mental Nerve of One Side
Eligibility Criteria
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.
Sites / Locations
- Faculty of Oral and Dental Medicine Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient lost sensation ant half of lower lip
Arm Description
patient with injured inferior alveolar nerve at one side
Outcomes
Primary Outcome Measures
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218474
Brief Title
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Official Title
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Basem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Mental Nerve of One Side
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient lost sensation ant half of lower lip
Arm Type
Other
Arm Description
patient with injured inferior alveolar nerve at one side
Intervention Type
Procedure
Intervention Name(s)
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Intervention Description
-sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one
Primary Outcome Measure Information:
Title
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed basem
Phone
00201159300386
Ext
asdsa
Email
ahmed_basem1234@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
3461143
Citation
Kaban LB, Upton J. Cross mental nerve graft for restoration of lip sensation after inferior alveolar nerve damage: report of case. J Oral Maxillofac Surg. 1986 Aug;44(8):649-51. doi: 10.1016/s0278-2391(86)80078-7. No abstract available.
Results Reference
result
Learn more about this trial
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
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