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Development and Validation of an Automated Three-dimensional Cephalometry Method

Development and Validation of an Automated Three-dimensional Cephalometry Method

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04464252
Acronym
AutoCEPH-3D
Enrollment
453
Registered
2020-07-09
Start date
2022-04-30
Completion date
2022-04-30
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentofacial Deformities, Orthognathic Surgery

Keywords

Imaging, three-dimensional, Cephalometry, Anatomic Landmarks, Radiographic Image Interpretation, Deep Learning, Orthodontics

Brief 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.

Interventions

None listed

Sponsors

Laboratoire de Biomécanique Georges Charpak
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Average distances (in mm) between the points placed automatically and the points placed manually (reference).through study completion, an average of 1 year

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026