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临床试验/NCT02466269
NCT02466269已完成不适用

A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach

Hui Li0 个研究点目标入组 1 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
主要终点
Change from facial nerve function at 24 hours postoperatively

研究概览

简要总结

A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint(TMJ)and to the zygomatic arch.

详细描述

Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury,the maximum mouth opening, mandibular movements, occlusion, scar formation,hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical and radiographical diagnosis of DFs;

排除标准

  • condylar fractures with undisplaced fractures;
  • Fractures without the reduction of the condylar height;
  • A obvious scar at the temporal region, affecting the placement of the original incision.

结局指标

主要结局

Change from facial nerve function at 24 hours postoperatively

时间窗: 24 hours

The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

Change from facial nerve function at 1 week postoperatively

时间窗: 1 week

The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

Change from facial nerve function at 3 months postoperatively

时间窗: 3 months

The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

Change from facial nerve function at 6 months postoperatively

时间窗: 6 months

The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

Change from facial nerve function at 12 months postoperatively

时间窗: 12 months

The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.

次要结局

未报告次要终点

研究者

发起方
Hui Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui Li

Principal Investigator

West China College of Stomatology

相似试验

Treatment of Diacapitular Condylar Fractures | 临床试验