Computer-Assisted Segmentation of Craniofacial Structures and Osteotomy Planning Using CBCT and CT

November 4, 2026 updated by: Hospital of the Ministry of Interior, Kielce, Poland

Development and Evaluation of Methods for Automatic and Semi-Automatic Segmentation of Craniofacial Structures and Delineation of Osteotomy Corridors Using CBCT and CT Imaging

This project will develop and evaluate methods for automatic and semi-automatic segmentation of craniofacial structures and delineation of osteotomy corridors using cone-beam computed tomography (CBCT) and computed tomography (CT) images. It will assess the quality and reproducibility of expert-prepared reference segmentations, the influence of model training, and the accuracy, processing time, and errors of automated methods. Only existing clinical scans will be used, with no additional imaging or changes to patient treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This retrospective methodological project will use pseudonymized CBCT and CT images. Expert-reviewed segmentations and virtual osteotomy plans will serve as references. Selected cases will undergo repeated and independent assessment to evaluate intra- and interobserver agreement. A development dataset of CBCT examinations will be used to assess the effects of training set size and training progression. The final model will be tested on examinations not used during development. Evaluation will include segmentation accuracy, processing time, errors, technical failures, and correction requirements. Osteotomy corridors will be assessed against reference plans and nearby critical anatomical structures.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Kielce, Poland, 25-375
        • Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.

Description

Inclusion Criteria:

  • Archived CBCT or CT examinations acquired for clinical indications.
  • Patient age of 16-85 years at the time of imaging.
  • Images available in DICOM format and suitable for analysis.
  • Complete visualization of the anatomical structures required for the planned analysis.
  • Image quality sufficient for reliable reference preparation and assessment.

Exclusion Criteria:

  • Incomplete or corrupted image series.
  • Insufficient imaging coverage.
  • Image quality preventing reliable reference assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with archived CBCT or CT examinations

Patients whose archived CBCT or CT examinations will be used to develop and evaluate automatic and semi-automatic craniofacial segmentation methods and virtual osteotomy planning.
Other: Computer-based craniofacial segmentation and osteotomy planning

Automatic and semi-automatic segmentation of craniofacial structures and virtual delineation of osteotomy corridors using archived CBCT and CT images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmentation accuracy compared with expert-prepared reference segmentations
Time Frame: At the time of final model evaluation, up to 6 months

Agreement between uncorrected algorithm-generated segmentation masks and expert-prepared reference masks, assessed using the Dice similarity coefficient (DSC). Scores range from 0 to 1, with higher values indicating greater overlap.
At the time of final model evaluation, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraobserver and interobserver agreement of reference segmentations
Time Frame: During initial, repeat, and independent reference segmentation assessments, up to 6 months

Agreement between repeated reference segmentations by the same investigator and independent reference segmentations by a second investigator, assessed using the Dice similarity coefficient (DSC). Scores range from 0 to 1, with higher values indicating greater overlap.
During initial, repeat, and independent reference segmentation assessments, up to 6 months
Segmentation processing time
Time Frame: During segmentation processing, up to 6 months

Time required to generate segmentations for the evaluated examinations.
During segmentation processing, up to 6 months
Frequency of segmentation errors, technical failures, and correction requirements
Time Frame: During segmentation processing and initial expert evaluation, up to 6 months

Frequency of segmentation errors, technical failures, restarts, and correction requirements, reported separately by category.
During segmentation processing and initial expert evaluation, up to 6 months
Segmentation performance by training set size and training progression
Time Frame: During model training and internal validation, up to 6 months

Dice similarity coefficient values across evaluated training set sizes and training stages during internal validation.
During model training and internal validation, up to 6 months
Evaluation of virtual osteotomy corridors
Time Frame: At the time of virtual osteotomy corridor evaluation, up to 6 months

Assessment of computer-generated osteotomy corridors against expert-prepared reference plans and in relation to nearby critical anatomical structures.
At the time of virtual osteotomy corridor evaluation, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of the Ministry of Interior, Kielce, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT/2026/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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