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Assessment of Nerve Function After Mandible Surgery With a Modified Bilateral Sagittal Split Osteotomy Technique

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Neurosensory Function of Inferior Alveolar Nerve

Treatments

Procedure: bilateral sagittal split osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02634840
CGMH-IRB-101-5264B (Other Identifier)
CMRPG381601-3

Details and patient eligibility

About

Several technical modifications based on the anatomical position of the neurovascular bundle and its bony mandibular canal have been developed, aiming to prevent injury to the intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD) should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce our modified BSSO technique and evaluate the subsequent incidence of postoperative neurosensory disturbance of the IAN.

Full description

The study was designed as a prospective cohort study. Consecutive patients scheduled for orthognathic surgery (OGS) conducted by the senior author at the Craniofacial Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital between January and August 2013 were asked to participate. OGS procedures included mandibular BSSO with or without maxillary LeFort I osteotomy or genioplasty. Fifty-seven patients were enrolled. All patients received cone-beam computed tomography before surgery for intra-alveolar nerve (IAN) assessment and virtual surgery planning.

During surgery, corticotomy and osteotomy lines are modified from the Obwegeser-Dal Pont method. After corticotomy completion, a Dautrey osteotome is driven into the mandible medulla via the anterior corticotomy, keeping constant contact to the inner side of the buccal ramus cortex for the first 10mm. The osteotome, located anterior and lateral to the IAN, is then twisted with moderate force, gradually separating the proximal and distal segment cortices along the anterior opening to facilitate visualization. Possible resistance to open the cortices indicates incomplete corticotomies located in the medial cortex, or the posterior and inferior aspects of both corticotomy lines. Before the complete split, the IAN is evaluated for any exposure through the anterior opening . If the IAN is exposed or attached to the outer cortex, it can gently be replaced into the distal segment. Under visualization through the anterior opening, a straight 4 or 6 mm osteotome is then inserted lateral to and passed beyond the IAN, and then hit to split the posterior ramus cortex along the inner surface of the proximal segment to reach the posterior border.

A standardized record form was provided to all subjects before and after surgery. Gender, preoperative diagnosis and operative details were collected, including surgical plan, mandibular movement extent and concomitant surgical procedures i.e. LeFort I and genioplasty, problematic mandibular splitting and type of fixation. All BSSO procedures were divided into independent left and right sides. After successful splitting of the mandibular ramus, splitting results were categorized.

A 5-point scale self-assessment questionnaire was used during the routine follow up visits to evaluate IAN neurosensory disturbance (NSD) after the BSSO procedure. The subjective neurosensory status evaluation was performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation returned.

Enrollment

57 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients receiving mandibular bilateral sagittal split osteotomy during orthognathic surgery with normal preoperative intraalveolar nerve function
  • patients with cleft lip/palate or hemifacial microsomia were also included

Exclusion criteria

  • craniofacial syndromic condition, abnormal psychomotor development or previous history of mandibular fracture

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Surgical intervention
Experimental group
Description:
Patients receiving our modified bilateral sagittal split osteotomy procedure during orthognathic surgery, "intervention arm" in prospective cohort study
Treatment:
Procedure: bilateral sagittal split osteotomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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