Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Class III Malocclusion
• Intervention / Treatment: Procedure: patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patient with class III malocclusion

Procedure: patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurosensory dysfunction of Inferior Alveolar Nerve	Neurosensory test: two-point discrimination test	one year after surgical intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohammed Omara, Lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): April 10, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: OMFS -1-10-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No