Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
Primary Purpose
Class III Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation
Sponsored by
About this trial
This is an interventional treatment trial for Class III Malocclusion
Eligibility Criteria
Inclusion Criteria:
- Adult patients.
- patients with skeletal class III malocclusion.
- Patients with thin mandibular rami with minimal medullary bone.
- Patients with inferior alveolar nerve proximity to the buccal cortex.
- Patients with lateral bending of the inferior mandibular border at molar angle region.
- Patients with high mandibular foramen.
Exclusion Criteria:
- Patients with previous extensive jaw surgery.
- mandibular pathological lesions.
- Patients with temporomandibular joint dysfunction.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with class III malocclusion
Arm Description
Outcomes
Primary Outcome Measures
Neurosensory dysfunction of Inferior Alveolar Nerve
Neurosensory test: two-point discrimination test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05397002
Brief Title
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
Official Title
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
April 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. The aim of this study is to introduce a novel modification of the intraoral inverted L ramus osteotomy (ILRO) to overcome these limitations in mandibular setback surgery. preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Inferior alveolar nerve function was regained perfectly one year post-operatively. This procedure introduces a robust alternative to the BSSO osteotomy in some cases of mandibular setback surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with class III malocclusion
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation
Intervention Description
preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Plane transfer was checked using CBCT and Inferior alveolar nerve function was assessed.
Primary Outcome Measure Information:
Title
Neurosensory dysfunction of Inferior Alveolar Nerve
Description
Neurosensory test: two-point discrimination test
Time Frame
one year after surgical intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients.
patients with skeletal class III malocclusion.
Patients with thin mandibular rami with minimal medullary bone.
Patients with inferior alveolar nerve proximity to the buccal cortex.
Patients with lateral bending of the inferior mandibular border at molar angle region.
Patients with high mandibular foramen.
Exclusion Criteria:
Patients with previous extensive jaw surgery.
mandibular pathological lesions.
Patients with temporomandibular joint dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Omara, Lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
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