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

4. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Polen
      • Kielce, Polen, 25-375
        • Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 85 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: OTHER
  • Tidsperspektiver: RETROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Segmentation accuracy compared with expert-prepared reference segmentations
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraobserver and interobserver agreement of reference segmentations
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital of the Ministry of Interior, Kielce, Poland

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

29. oktober 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CT/2026/3

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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