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

Study Overview
=================
Brief Summary
-----------------
Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT

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

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

Conditions
-----------------
Segmentation Techniques

Intervention / Treatment
-----------------
* Radiation: CBCT radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intact dry human skulls and mandibles. Exclusion Criteria: Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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