Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT (CBCT)

October 5, 2022 updated by: Enas El Saket, Cairo University

Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT(A Diagnostic Accuracy Study)

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

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

It will be used to segment the mandibular condyle and asses its volumetric and linear measurements. Therefore, the accuracy of the segmentation techniques of the mandibular condyle will be determined

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intact dry human skulls and mandibles.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual segmentation technique of CBCT images of the condyles.
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
CBCT scanning
Experimental: Semiautomatic segmentation technique of CBCT images of the condyles.
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.
CBCT scanning
No Intervention: Actual physical measurements of the condyles on the dry mandibles

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear assessment of the condyles
Time Frame: one month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric assessment of the condyles
Time Frame: one month
For volumetric measurements, the volume of the segmented condyle, either by manual or semiautomatic segmentation technique, will be automatically calculated by the software. Volumetric measurements will be calculated in cubic millimeters.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

November 20, 2022

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RAD 7:1-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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