Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine & Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

Study Overview

• Status: Not yet recruiting
• Conditions: CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose
• Intervention / Treatment: Radiation: CBCT

Detailed Description

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine & Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

R (Reference standard): Physical real linear measurements of the condyles will be considered as reference standard, where distances will be measured by digital caliper on the dry human in millimeters as supported by García-Sanz et al. (2017) & (Kim et al., 2020).

Volumetric measurements form the dry human condyles will be considered as reference standard where water displacement method will be used (according to Archimedes' principle), by immersion of the condyle under investigation in a water filled graduated transparent glass container, after being hangered from a L-shaped metal hanger by using a rope, till the complete immersion of the condylar volume (which was demarcated by using the gutta percha points) under the water level, this will provide more standardization. Then, the displaced amount of water, will be observed and then aspirated by a graduated pipette to calculate its volume in cubic millimeters. This technique was supported by García-Sanz et al. (2017).

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. mandibles with sound condyles
2. skulls with sound glenoid fossa.

Exclusion Criteria:

1. skulls with fractured glenoid fossa,
2. glenoid fossa with developmental deformities,
3. mandibles with fractured condylar neck or head,
4. presence of pathological lesions,
5. fracture,
6. Shipping,
7. developmental deformities in the condyle.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear Measurements	Linear assessment will be done by applying the same landmarks on the both segmented condyles (yielded rom Conventional and Ultralow dose CBCT imaging), Distances will be measured on the segmented condyles from the segmentation software in millimeters. The linear distances according to García-Sanz et al. (2017) will be as follows: Line 1: Condylar width measured as the distance between lateral and medial landmarks.; Line 2: Condylar length measured as distance between anterior and posterior landmarks.; Line 3: Condylar height measured as distance of the perpendicular line traced from superior point to line 1.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric measurements	Volumetric assessment will be done by calculating both segmented condylar volumes (yielded from Conventional and Ultralow dose CBCT imaging) by the segmentation software in cubic millimeters.	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): July 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ORAD7-1-1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No