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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

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

Treatments

Radiation: CBCT

Study type

Interventional

Funder types

Other

Identifiers

NCT05441423
ORAD7-1-1-1

Details and patient eligibility

About

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.

Full 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).

Enrollment

29 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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