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

NCT05441423 | Unknown DMC

• 1 other identifier: ORAD7-1-1-1
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Volumetric measurements

  1 year

Interventions

CBCT RADIATION

CBCT Scans. conventional \& ultra low dose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• mandibles with sound condyles
• skulls with sound glenoid fossa.

You may not qualify if:

• skulls with fractured glenoid fossa,
• glenoid fossa with developmental deformities,
• mandibles with fractured condylar neck or head,
• presence of pathological lesions,
• fracture,
• Shipping,
• developmental deformities in the condyle.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. Human skulls and mandibles will be recruited according to the following eligibility criteria: inclusion criteria will be mandibles with sound condyles and skulls with sound glenoid fossa. Exclusion criteria will be skulls with fractured glenoid fossa, or glenoid fossa with developmental deformities, mandibles with fractured condylar neck or head, presence of pathological lesions, fracture, Shipping, or developmental deformities in the condyle.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share