CClinicalTrials.gg
CompletedNCT04475237Updated Aug 3, 2021

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

An observational study in Mandibular Diseases and SSM, sponsored by CADskills. Completed at 1 site in Belgium. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by CADskills · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
100
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Mandibular Diseases
  • SSM
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

European adults

Inclusion criteria

  • Healthy mandibles

Exclusion criteria

Exclusion Criteria:

  • Mandibles with major deformities
  • Mandibles with obvious problems
  • Mandibles that already underwent surgery
04

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy mandibles

    Belgian adults (between 20 and 60 years old), 50/50 male/female, with no major mandibular problems/deformities

    Other: CT-scan evaluation and segmentation

Interventions

  • OtherCT-scan evaluation and segmentation

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

05

What researchers measure

Primary outcomes

  1. A statistical shape model of a mandible

    A statistical shape model of a mandible

    Time frame: 2 months

06

Study locations

1 site
  • CADskills HQ
    Ghent, East-Flanders 9051, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04475237
Lead sponsor
CADskills
Responsible party
Sponsor
First posted
Jul 17, 2020
Start date
Jan 1, 2020
Primary completion
May 1, 2021
Completion
May 5, 2021
Last update
Aug 3, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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