- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435417
Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT (CBCT)
Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT(A Diagnostic Accuracy Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Recruiting
- Faculty of Dentistry, Cairo University
-
Contact:
- Enas El Saket, PHD degree
- Phone Number: +201001243575
- Email: enas_saket@dentistry.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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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
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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