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

Mandibular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475237
• Other study ID #: SSM
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: May 5, 2021

Study information

• Verified date: August 2021
• Source: CADskills
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 5, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy mandibles

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mandibular Diseases
• SSM

Intervention

Other:
• CT-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.

Locations

Country	Name	City	State
Belgium	CADskills HQ	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
CADskills

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A statistical shape model of a mandible	A statistical shape model of a mandible	2 months