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

NCT02634840 | Completed

• 2 other identifiers: CMRPG381601-3CGMH-IRB-101-5264B
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neurosensory Function of Inferior Alveolar Nerve

Keywords

inferior alveolar nerve; neurosensory disturbance; bilateral sagittal spilt osteotomy; mandibular surgery; neurosensory function

Outcome Measures

Primary Outcomes (1)

• Incidence of NSD 12 months postoperatively in relation to IAN exposure during surgery

  For every patient, the incidence of IAN exposure is recorded. The incidence of NSD is evaluated 12 months after the procedure. The relation and statistical significance is documented with Chi-square-test.

  preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam

Secondary Outcomes (3)

• Longitudinal incidence of NSD in relation to gender, age, affected side, preexisting deformity, third molar extraction and genioplasty

  preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam

• Longitudinal incidence of NSD in relation to split type during surgery

  preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam

• Longitudinal incidence of NSD in relation to IAN exposure

  preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam

Study Arms (1)

Surgical intervention

EXPERIMENTAL

Patients receiving our modified bilateral sagittal split osteotomy procedure during orthognathic surgery, "intervention arm" in prospective cohort study

Procedure: bilateral sagittal split osteotomy

Interventions

bilateral sagittal split osteotomy PROCEDURE

surgical technique to split the mandibular ramus through three osteotomy lines on the medial-cranial, buccal-caudal and anterior surface to facilitate a split of the posterior border of the mandible without injury of the inferior alveolar nerve

Also known as: bilateral ramus sagittal split osteotomy

Surgical intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (7)

• Obwegeser HL. Orthognathic surgery and a tale of how three procedures came to be: a letter to the next generations of surgeons. Clin Plast Surg. 2007 Jul;34(3):331-55. doi: 10.1016/j.cps.2007.05.014.

  PMID: 17692696 BACKGROUND

• Westermark A, Bystedt H, von Konow L. Inferior alveolar nerve function after sagittal split osteotomy of the mandible: correlation with degree of intraoperative nerve encounter and other variables in 496 operations. Br J Oral Maxillofac Surg. 1998 Dec;36(6):429-33. doi: 10.1016/s0266-4356(98)90458-2.

  PMID: 9881784 BACKGROUND

• Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.

  PMID: 11078134 BACKGROUND

• Kane AA, Lo LJ, Chen YR, Hsu KH, Noordhoff MS. The course of the inferior alveolar nerve in the normal human mandibular ramus and in patients presenting for cosmetic reduction of the mandibular angles. Plast Reconstr Surg. 2000 Oct;106(5):1162-74; discussion 1175-6. doi: 10.1097/00006534-200010000-00029.

  PMID: 11039388 BACKGROUND

• Hanzelka T, Foltan R, Pavlikova G, Horka E, Sedy J. The role of intraoperative positioning of the inferior alveolar nerve on postoperative paresthesia after bilateral sagittal split osteotomy of the mandible: prospective clinical study. Int J Oral Maxillofac Surg. 2011 Sep;40(9):901-6. doi: 10.1016/j.ijom.2011.04.002. Epub 2011 May 13.

  PMID: 21570811 BACKGROUND

• Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.

  PMID: 17719387 BACKGROUND

• Agbaje JO, Salem AS, Lambrichts I, Jacobs R, Politis C. Systematic review of the incidence of inferior alveolar nerve injury in bilateral sagittal split osteotomy and the assessment of neurosensory disturbances. Int J Oral Maxillofac Surg. 2015 Apr;44(4):447-51. doi: 10.1016/j.ijom.2014.11.010. Epub 2014 Dec 9.

  PMID: 25496848 BACKGROUND

Study Officials

• Lun-Jou Lo, MD

  Chairman, Department of Surgery, Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: January 6, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share