Clinical trial NCT05441423: Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)
Official title: Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CBCT - Condyle - Semi-automated Segmentation - Ultra-low Dose
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Linear Measurements
timeFrame: 1 year
Secondary outcomes:
measure: Volumetric measurements
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
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