An observational study in Craniofacial Structure Segmentation and Virtual Osteotomy Planning, sponsored by Hospital of the Ministry of Interior, Kielce, Poland. Not yet recruiting at 1 site in Poland. Open to participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hospital of the Ministry of Interior, Kielce, Poland · Observational
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.
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.
Hospital of the Ministry of Interior, Kielce, Poland is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Segmentation accuracy compared with expert-prepared reference segmentations
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.
Time frame: At the time of final model evaluation, up to 6 months
Intraobserver and interobserver agreement of reference segmentations
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.
Time frame: During initial, repeat, and independent reference segmentation assessments, up to 6 months
Segmentation processing time
Time required to generate segmentations for the evaluated examinations.
Time frame: During segmentation processing, up to 6 months
Frequency of segmentation errors, technical failures, and correction requirements
Frequency of segmentation errors, technical failures, restarts, and correction requirements, reported separately by category.
Time frame: During segmentation processing and initial expert evaluation, up to 6 months
Segmentation performance by training set size and training progression
Dice similarity coefficient values across evaluated training set sizes and training stages during internal validation.
Time frame: During model training and internal validation, up to 6 months
Evaluation of virtual osteotomy corridors
Assessment of computer-generated osteotomy corridors against expert-prepared reference plans and in relation to nearby critical anatomical structures.
Time frame: At the time of virtual osteotomy corridor evaluation, up to 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hospital of the Ministry of Interior, Kielce, Poland