Trials / Completed
CompletedNCT04464252
Development and Validation of an Automated Three-dimensional Cephalometry Method
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 453 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.
Detailed description
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.
Conditions
Timeline
- Start date
- 2022-04-30
- Primary completion
- 2022-04-30
- Completion
- 2022-04-30
- First posted
- 2020-07-09
- Last updated
- 2022-10-31
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04464252. Inclusion in this directory is not an endorsement.