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临床试验/NCT03647865
NCT03647865Unknown不适用

Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty

Cairo University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Accuracy Of the Custom Made Miniplate

研究概览

简要总结

In patients with chin deformeties, will using a custom made titanium plate in the positioning of the genial segments give an accurate results in comparison to the preoperative planned osteotomy and move of the Genioplasty.

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

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with genial deformeties that require surgical correction.
  • •Patients with chin asymmetry.
  • •Patients older than 18 years old.

排除标准

  • •Patients with uncontrolled systemic disease (Diabetes Mellitus).
  • •Previous Radiotherapy to the area of interest.
  • •Patients on bisphosphonates therapy.
  • •Patients underwent previous or concomitant mandibular orthognathic surgery.

研究组 & 干预措施

Patients need genioplasty

Experimental

干预措施: Osseous Genioplasty (Procedure)

结局指标

主要结局

Accuracy Of the Custom Made Miniplate

时间窗: one year

Hausdorff function analysis (Topographic Color Mapping) by superimposition of both preoperative and postoperative computed tomography 3D scans and obtaining numerical values. Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) vs.21. Numerical data will be summarized using means and standard deviations or median and range as appropriate. Correlation analysis between Accuracy of computer assisted custom made plate and preoperative 3D virtual planning will be done using Pearson or Sperman rho as appropriate. Paired t test will be done and equivelance limit will be tested. All p- values are two sided. P- Values \<0.05 will be considered significant.

次要结局

  • Patient Satisfaction (Esthetics)(one year)

研究者

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

Mina Nazih Zaki Sedrak

Principal Investigator

Cairo University

研究点 (1)

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