Computer-Assisted Segmentation of Craniofacial Structures and Osteotomy Planning Using CBCT and CT
Craniofacial Structure Segmentation · Virtual Osteotomy Planning
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 16 years - 85 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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
Computer-based craniofacial segmentation and osteotomy planning OTHER
Automatic and semi-automatic segmentation of craniofacial structures and virtual delineation of osteotomy corridors using archived CBCT and CT images.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
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.
Segmentation processing time
Time frame: During segmentation processing, up to 6 months
Time required to generate segmentations for the evaluated examinations.
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.
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.
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Department of Maxillofacial Surgery, Hospital of the Ministry of InteriorKielce, PolandStatus unknown
Study team and timeline
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, Poland
- Study start
- 2026-11 Estimated
- Primary completion
- 2027-03 Estimated
- Study completion
- 2027-04 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Development and Evaluation of Methods for Automatic and Semi-Automatic Segmentation of Craniofacial Structures and Delineation of Osteotomy Corridors Using CBCT and CT Imaging
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026