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

NCT ID: NCT03719235

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-09-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Cone Beam Computed Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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column

ultra-low dose CBCT versus digital panoramic radsiography

Group Type OTHER

CBCT

Intervention Type OTHER

ultra-low dose CBCT

Interventions

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CBCT

ultra-low dose CBCT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 10 to 70 years
* no gender nor race predilection
* Either dentulous or edentulous are acceptable.

Exclusion Criteria

* fractures
* pathology
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hala Wafik Mohamed El Fayoumy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hala wk el fayoumy

Role: CONTACT

01112222565 ext. cairo

mohamed md el sawy

Role: CONTACT

01005001650 ext. cairo

Facility Contacts

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hala wk elfayoumy

Role: primary

01112222565

mohamed md el sawy

Role: backup

01005001650

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HWEF

Identifier Type: -

Identifier Source: org_study_id

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