NCT05435417

Brief Summary

Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

June 23, 2022

Last Update Submit

October 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Linear assessment of the condyles

    Linear measurements will be calculated in millimeters by Built-in measuring tool (ruler) in the software + digital caliper on the dry mandibles

    one month

Secondary Outcomes (1)

  • Volumetric assessment of the condyles

    one month

Study Arms (3)

Manual segmentation technique of CBCT images of the condyles.

EXPERIMENTAL

Using the manual edition built in tool, first a brush of small size will be used to demarcate the outline of the condyle in the sagittal cuts. Then shading the demarcated condylar area with a brush of larger size in each slice. The outline of the condyle will be refined on all cuts. The software built in tool 'create surface' will be used to create the segmented 3D volume

Radiation: CBCT radiation

Semiautomatic segmentation technique of CBCT images of the condyles.

EXPERIMENTAL

Using the water shed built in tool, first a brush of small size will be used to demarcate the outline of the condyle by the 'background' option in all planes. Then using the 'foreground' option, a brush of larger size will be used to shade the condylar area. The software built in tool 'expand water shed' will be used to include the whole condyle. At last, 'create surface' option will be used to create the segmented 3D volume.

Radiation: CBCT radiation

Actual physical measurements of the condyles on the dry mandibles

NO INTERVENTION

For linear measurements, actual physical measurements will be done on the dry mandibular condyles, using digital caliper, as mentioned before. For volumetric measurements, water displacement technique will be used. The mandibular condyle will be immersed in a graduated beaker containing water till the level of the glued gutta percha. The volume of the displaced water will be measured and will represent the actual volume of the condyle

Interventions

CBCT scanning

Manual segmentation technique of CBCT images of the condyles.Semiautomatic segmentation technique of CBCT images of the condyles.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Intact dry human skulls and mandibles.

You may not qualify if:

  • Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

July 1, 2022

Primary Completion

November 20, 2022

Study Completion

December 30, 2025

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations