An interventional study of patient specific inverted L mandibular osteotomy modified with inferior alveolar nerve relocation in Class III Malocclusion, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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.
Neurosensory dysfunction of Inferior Alveolar Nerve
Neurosensory test: two-point discrimination test
Time frame: one year after surgical intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Apr 2022, 18 months.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 18 months is above that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →