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临床试验/NCT06005467
NCT06005467尚未招募不适用

The Effect of (v) Shaped Plate on Occlusion and Condylar Position Compared to Champy Technique in Fixation of Mandibular Angle Fracture (Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8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
尚未招募
入组人数
40
试验地点
1
主要终点
proper occlusion

研究概览

简要总结

assessing fixation of mandibular angle fracture using two different mini plates, the standard champy technique and the new V shaped plate with comparing occlusion and condylar position between the two plates.

详细描述

The mandible is one of the most frequent bones of the face that is susceptible to fractures because its prominent position, as it comes in the second place after nasal fractures . Mostly, such fractures are a result of trauma caused by vehicle accidents, physical altercations, industrial accidents, falls, and contact sports, males usually suffer from mandibular fractures more than females.

The angle of the mandible is the most frequent area of the mandible to be fractured after the body, the reasons behind that is the presence of a third molar especially if it was impacted one which weakens the region even more, another reason is the existence of a very thin cross sectional area compared to the anterior parts of the mandible. Most common causes of mandibular angle fractures are motor vehicle collisions and assaults or altercations.

Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy reduction and stabilized fixation along both sides of the fracture, as it has two arms that can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis along the superior border and lateral surface of the external oblique ridge using a single plate.

Although champy technique has been proven to be successful way for treating angle fractures with low complication rates it covers only one line of osteosynthesis which is the superior border of external oblique ridge unlike the (v) shaped plate.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with unilateral angle fracture.
  • •Patients free from any systemic diseases that affect bone healing.
  • •No sex predilection.

排除标准

  • •Comminuted angle fractures.
  • •Infected angle fracture.
  • •Bilateral angle fracture.
  • •Patients with any systemic diseases that affect bone healing.

研究组 & 干预措施

V shaped plate

Experimental

its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.

干预措施: Open reduction and internal fixation of mandibular angle fracture using V shaped plate (Procedure)

champy technique

Active Comparator

champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.

干预措施: Open reduction and internal fixation of mandibular angle fracture using V shaped plate (Procedure)

结局指标

主要结局

proper occlusion

时间窗: 1 week- 3 months and 6 months

It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.

次要结局

  • condylar position(6 months)

研究者

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

Rasha Tohamy Abdelsattar Mohammed

Master's degree candidate

Cairo University

研究点 (1)

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