Development and Validation of an Automated Three-dimensional Cephalometry Method

Orthognathic Surgery Clinical Trial

— AutoCEPH-3D  

Official title:

Development and Validation of an Automated Three-dimensional Cephalometry Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464252
• Other study ID #: APHP200215
• Status: Completed
• Start date: April 30, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. Patients followed in the maxillofacial surgery department of Pitie-Salpetriere hospital (AP-HP, Paris, France) since 2014;

2. who underwent orthognathic surgery;

3. who had, for surgery planning, a three-dimensional radiographic examination (CT-Scan) which has been segmented for the manufacture of a custom-made device;

4. who did not object to the research.

Related Conditions & MeSH terms

• Dentofacial Deformities
• Orthognathic Surgery

Locations

Country	Name	City	State
France	Service de Chirurgie Maxillo-Faciale, Service de Chirurgie Maxillo-Faciale	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Laboratoire de Biomécanique Georges Charpak

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average distances (in mm) between the points placed automatically and the points placed manually (reference).		through study completion, an average of 1 year
Secondary	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