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Completed

NCT Number: NCT04464252

Development and Validation of an Automated Three-dimensional Cephalometry Method

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

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Maxillo-Faciale, Service de Chirurgie Maxillo-Faciale

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Percentage of points placed automatically within 2 / 3 / 4 mm of the the points placed manually (reference)

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Laboratoire de Biomécanique Georges Charpak

Registry information

Acronym: AutoCEPH-3D

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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