NCT04475237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

July 14, 2020

Last Update Submit

August 2, 2021

Conditions

Mandibular DiseasesSSM

Outcome Measures

Primary Outcomes (1)

  • A statistical shape model of a mandible

    A statistical shape model of a mandible

    2 months

Study Arms (1)

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

CT-scan evaluation and segmentationOTHER

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

Healthy mandibles

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

European adults

You may qualify if:

  • Healthy mandibles

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CADskills HQ

Ghent, East-Flanders, 9051, Belgium

Location

MeSH Terms

Conditions

Mandibular Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

January 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 5, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)