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OpenTrials
Completed

NCT Number: NCT04475237

Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model

Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.

Completed

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CADskills HQ

Ghent, East-Flanders, 9051, Belgium

About this study

Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). First, they will be anonymized (except the sex and age/date of birth). Afterwards, they will be segmented using Materialise Mimics software. The segmented mandibles will then be used to create a statistical shape model (SSM) using principal component analysis. This model will afterwards be used to predict the mandibular shapes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy mandibles

Exclusion criteria

  • Mandibles with major deformities
  • Mandibles with obvious problems
  • Mandibles that already underwent surgery

Treatment and study plan

CT-scan evaluation and segmentation

Other

CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.

Primary outcomes

  1. A statistical shape model of a mandible

    Time frame: 2 months

    A statistical shape model of a mandible

Sponsors and collaborators

Lead sponsor

CADskills

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2020
Registry last updated
Aug 3, 2021

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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