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临床试验/NCT05467618
NCT05467618已完成不适用

Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible

Ayub Teaching Hospital2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
2
主要终点
Indication of post-surgical infections

研究概览

简要总结

This study compared the surgical approach to the lower jaw fractures, an approach from the face and an approach from inside the mouth were used and compared for the outcomes.

详细描述

Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 The pattern of mandibular fractures varies with geographic location, physical activity, social, cultural and environmental factors. The main causes 4,5 of mandibular fracture are; Road traffic accidents, interpersonal violence, falls, sports injuries, industrial trauma, pathological fractures etc. In developing countries road traffic accident 6 is the common cause of mandibular fractures due to lack of implementation of traffic laws while in developing countries alcohol related7 interpersonal violence is the leading cause. Any age and sex group may sustain trauma to the lower jaw but children below the age of 12 years are less susceptible to fracture because their bones are more resilient.5,6 Different modalities available for the treatment of mandibular fractures are: Maxillo mandibular fixation (MMF) alone e.g. dental wiring, arch bar etc.8 Previously traditional methods i.e. maxillomandibular fixation and transosseous wiring were the most popular methods used for mandibular fracture fixation. These are still commonly used methods9 and have got various disadvantages such as preventing normal jaw function, weight loss due to restriction of food to liquid consistency, oral hygiene problem and reduction of ventilatory volume.,10 Currently, fixation with one or two mini- plates has become a widely acceptable method of providing internal fixation and eliminating the need for post-operative maxillo mandibular fixation. The fixation of mandibular angle can be carried out by two methods i.e. Intra oral approach8, and Extra oral approach. For intra oral approach buccal sulcus incision while for extra oral approach sub-mandibular (Risdon),11 incision is given. Postoperative complications related to both types of treatment modalities were observed in intra oral approach 13.3 % and extra oral approach 16.6% infection and limited opening were observed in intra oral approach 6.6% and extra oral approach 16.6%.12 Rationale of this study is to compare post-operative complication of intra oral approach and extra oral approach in reduction of mandibular angle fracture in terms of infection and limited mouth opening. In our study, if we find less complication of intra-oral approach in significant number of patients, we will strongly recommend its routine use in the reduction of pain and limited mouth opening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 16 to 60 years
  • Both Genders.
  • Patients undergoing surgery for mandibular angle fracture

排除标准

  • Pathological fractures.
  • Condylar and sub-condylar fractures.
  • Edentulous patients.
  • Fire arm injury (FAI).
  • Fractures of the middle third of face.

结局指标

主要结局

Indication of post-surgical infections

时间窗: Up to three weeks

Redness, swelling, pain, bleeding, or any discharge

Limited jaw opening

时间窗: Up to three weeks

Mouth opening considered limited if the patient can only open mouth to a width of less than the width of his/her three fingers (index, middle, ring).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahid ali shah

Assistant Professor

Ayub Teaching Hospital

研究点 (2)

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