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Completed

NCT Number: NCT05397002

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation

Procedure

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 outcomes

  1. Neurosensory dysfunction of Inferior Alveolar Nerve

    Time frame: one year after surgical intervention

    Neurosensory test: two-point discrimination test

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 31, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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