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临床试验/NCT05647460
NCT05647460招募中不适用

Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture

Cairo University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
26
试验地点
2
主要终点
computer tomoghraphy

研究概览

简要总结

  • Preoperative CT.
  • Virtual reduction of broken segments on software.
  • Gain occlusion.
  • Design surgical screw holes locating guide.
  • Design the custom-made plates.
  • Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.

详细描述

Interventions 26 patients involved in this study will be divided in to two different groups, first group will be reduced using patient computer guided specific screw holes locating guide and custom-made plates.

Second group fractures will be reduced by conventional work flow.

Clinical evaluation:

A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.

A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with parasymphseal mandibular class fracture needs open reduction and internal fixation.
  • Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
  • Both genders males and females will be included.

排除标准

  • • • General contraindications to surgery.
  • Patients with fresh fractures (mobile segments).
  • Patients with unfavourable nor comminuted fractures.
  • Subjected to irradiation in the head and neck area less than 1 year before fixation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Patients participating in other studies, if the present protocol could not be properly followed.

结局指标

主要结局

computer tomoghraphy

时间窗: 3 months .

the Computer Tomography Will calculate the segments deviation in mm.

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

ahmed abd ellati tag eldin ahmed

master degree researcher

Cairo University

研究点 (2)

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