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临床试验/NCT03747666
NCT03747666Unknown不适用

Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures

Cairo University0 个研究点目标入组 20 人开始时间: 2019年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Biting force

研究概览

简要总结

Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

详细描述

Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
  • Fractures amenable to treatment using intra oral approach.

排除标准

  • Medically compromised patients who are unfit for the procedure under general anesthesia.
  • Patients with comminuted fractures.
  • Patients with history of occlusion disturbances or skeletal malocclusion.
  • Patients with insufficient dentition to reproduce occlusion.

研究组 & 干预措施

Locking miniplate

Experimental

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.

干预措施: 2.0 single locking miniplates (Procedure)

Non-locking miniplates

Experimental

The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.

干预措施: 2.0 single locking miniplates (Procedure)

结局指标

主要结局

Biting force

时间窗: 6 months

Biting force will be measured using occlusal biting force meter (Higher biting force record is better)

次要结局

  • Stability of fractured segments(6 weeks)
  • Pain intensity(10 days)
  • Paraesthesia(6 months)
  • Hardware failure(6 months)
  • Wound dehiscence(6 months)
  • Occlusion(6 months)
  • Infection(6 months)

研究者

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

Hany Abdelkader Hussein

Principal Investigator

Cairo University

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