Effect of CBCT Dose Reduction on the Mandibular Canal Visibility Compared to Standard CBCT Dose Diagnostic Accuracy Study

NCT07442474 | Completed DMC

• 1 other identifier: ORAD 711
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the diagnostic accuracy of CBCT dose reduction on the mandibular canal visibility, and their effect on canal cortication compared to standard CBCT dose as a gold standard. The main question it aims to answer is: Will the lower CBCT doses affect the visualization of mandibular canal when compared to standard CBCT dose as a gold standard?

Conditions

Mandibular Canal Visibility; Dose Reduction

Outcome Measures

Primary Outcomes (1)

• Primary outcome Evaluation of the diagnostic accuracy of the lowest CBCT dose (Milliampere: 2.2 mA.) compared to the gold standard CBCT dose (Milliampere: 10 mA.) on the mandibular canal visibility.

  March 2024

Study Arms (6)

I1: Conventional dose CBCT imaging

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 8 mA. * Exposure time: 13.5s * Voxel size: 0.4 mm

Diagnostic Test: CBCT imaging

I2: Conventional dose CBCT imaging

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 5.6 mA. * Exposure time: 9 s * Voxel size: 0.6 mm

Diagnostic Test: CBCT imaging

I3: CBCT imaging with Ultra low dose

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 7.1 mA. * Exposure time: 6 s * Voxel size: 0.2 mm

Diagnostic Test: CBCT imaging

I4: CBCT imaging with Ultra low dose

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 5.6 mA. * Exposure time: 4.5s * Voxel size: 0.4 mm.

Diagnostic Test: CBCT imaging

I5: CBCT imaging with Ultra low dose

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 2.2 mA. * Exposure time: 4.5 s * Voxel size: 0.6 mm.

Diagnostic Test: CBCT imaging

R (Reference standard): CBCT imaging with standard dose

exposure parameters: * Kilovoltage: 90 kVp. * Milliampere: 10 mA. * Exposure time: 18s * Voxel size: 0.2 mm.

Diagnostic Test: CBCT imaging

Interventions

CBCT imaging DIAGNOSTIC_TEST

Each dry human mandible will be scanned 6 times (3 conventional CBCT protocols and 3 Ultra-low CBCT protocols)

I1: Conventional dose CBCT imaging; I2: Conventional dose CBCT imaging; I3: CBCT imaging with Ultra low dose; I4: CBCT imaging with Ultra low dose; I5: CBCT imaging with Ultra low dose; R (Reference standard): CBCT imaging with standard dose

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dry human mandibles that will be recruited from Anatomy Department, Faculty of Medicine, Cairo University.

You may qualify if:

• sound mandibles

You may not qualify if:

• fractured mandibles

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: January 4, 2023
• Primary Completion: March 23, 2024
• Study Completion: May 20, 2024
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)