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临床试验/NCT04464252
NCT04464252已完成不适用

Development and Validation of an Automated Three-dimensional Cephalometry Method

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2022年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
453
试验地点
1
主要终点
Average distances (in mm) between the points placed automatically and the points placed manually (reference).

研究概览

简要总结

This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.

详细描述

Cephalometric analysis is a standardized diagnostic method used daily by orthodontists and maxillofacial surgeons. It is based on linear and angular measurements performed on radiographic images. This examination is traditionally done manually on two-dimensional radiographs, which does not allow to analyze finely the bilateral structures which are found superimposed. Cephalometric analysis of three-dimensional imaging (cone beam computed tomography (CBCT) or computed tomography scan (CT-Scan)) may provide additional diagnostic information, particularly for patients with maxillofacial abnormalities or marked asymmetries.

One of the obstacle to the clinical use of three-dimensional cephalometric analysis is the time and expertise needed to manually place the landmarks. Automatic methods described in literature are preliminary and lack validation in a clinical context.

Our retrospective observational study is aimed to develop and validate a new automated three-dimensional cephalometry method. This method will be based on a deep learning algorithm trained from a database of pre-surgery CT-Scans of patients with have undergone an orthognathic surgery. These CT-Scans will be manually annotated to provide a reference standard for the training of the algorithm and its evaluation. The validation of our results will focus on demonstrating the diagnostic effectiveness and robustness of three-dimensional cephalometric measurements obtained in this clinical context.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients followed in the maxillofacial surgery department of Pitie-Salpetriere hospital (AP-HP, Paris, France) since 2014;
  • who underwent orthognathic surgery;
  • who had, for surgery planning, a three-dimensional radiographic examination (CT-Scan) which has been segmented for the manufacture of a custom-made device;
  • who did not object to the research.

排除标准

  • 未提供

结局指标

主要结局

Average distances (in mm) between the points placed automatically and the points placed manually (reference).

时间窗: through study completion, an average of 1 year

次要结局

  • Percentage of points placed automatically within 2 / 3 / 4 mm of the the points placed manually (reference)(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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