跳至主要内容
临床试验/NCT02634840
NCT02634840已完成不适用

A Modified Technique of Mandibular Ramus Sagittal Split Osteotomy for Prevention of Inferior Alveolar Nerve Injury: A Prospective Cohort Study and Outcome Assessment

Chang Gung Memorial Hospital0 个研究点实际入组 57 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
主要终点
Incidence of NSD 12 months postoperatively in relation to IAN exposure during surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Surgical intervention

Experimental

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

干预措施: bilateral sagittal split osteotomy (Procedure)

结局指标

主要结局

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

时间窗: 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

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.

次要结局

  • 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 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 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)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
其他
责任方
申办方

标识符

NCT 编号
NCT02634840
其他研究编号
CMRPG381601-3, CGMH-IRB-101-5264B

日期

首次提交
(10年前)
首次发布
(10年前)
主要完成日期
(11年前)
研究完成日期
(11年前)
最近核实
(10年前)
最近更新
(10年前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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