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临床试验/NCT07729345
NCT07729345进行中(未招募)不适用

Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
radiographic assessment of accuracy in mandibular body fractures management

研究概览

简要总结

The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile.

But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.

详细描述

In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.
  • -Dentate adult patients.
  • All ages and both sexes were included in this study.

排除标准

  • Patients with systemic disease (may affect normal healing).
  • Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
  • Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

结局指标

主要结局

radiographic assessment of accuracy in mandibular body fractures management

时间窗: 3 months

using Mimics software

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

Nahla Mahmoud Awad

associate professor of oral and maxillofacial surgery

Cairo University

研究点 (1)

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