Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography

Cone Beam Computed Tomography Clinical Trial

— CBCT  

Official title:

Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography Performed on Mandibular Anaesthetic Landmarks Versus Real Mandibular Measurements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03719235
• Other study ID #: HWEF
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: September 10, 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: hala wk el fayoumy
• Phone: 01112222565
• Email: halaelfayoumy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

measurements performed directly on dry mandibles will be compared with measurements obtained from CBCT( ultra-low dose) scans and Digital panoramic radiography.

Description:

Mandibular anaesthetic landmarks will be identified on each dry mandible and will be marked using gutta percha.

The ten human dry mandibles will be submitted for:

1. Digital Panoramic Radiography. Panoramic radiographs will be obtained using the SOREDEX CRANEX™ 3Dx unit. The exposure parameters will be 8Ma, 63kVp and 16.4 sec exposure time.

2. Cone Beam Computed Tomography (CBCT). SOREDEX CRANEX™ 3Dx unit will be used in this study. Images will be acquired at a single rotation. SOREDEX® MiniDose parameters will be used. The exposure parameters will be 3.2 Ma, 90kVp and 2.3 sec exposure time to take the advantage of 3D data in dose sensitive cases like children, or reduce the radiation dose for the patient.

The real linear measurements will be measured in millimeter on dry mandibles using digital caliper and will be compared with measurements obtained from both techniques.

Images will be evaluated by two experienced radiologists of ten years of experience. Each one will evaluate the images separately twice with a period of two weeks in-between the two reading sessions. The researcher will measure out the real linear measurements on the dry mandibles using digital caliper.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 10 to 70 years

• no gender nor race predilection

• Either dentulous or edentulous are acceptable.

Exclusion Criteria:

• fractures

• pathology

Related Conditions & MeSH terms

• Cone Beam Computed Tomography

Intervention

Other:
• CBCT
ultra-low dose CBCT

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of diagnostic accuracy of linear measurements	measurements made on dry mandibles will be compared with measurements obtained from CBCT scans & digital panoramic radiography	within 2 years