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Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners

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ClinicalTrials.gov Identifier: NCT03103802
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Moahmed Amr Labib, Cairo University

Brief Summary:
This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements

Condition or disease Intervention/treatment Phase
Orthodontics Device: intra-oral digital scanner and extra-oral digital scanner Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)
Estimated Study Start Date : April 30, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : February 27, 2018

Arm Intervention/treatment
Experimental: Intra-oral scanning Device: intra-oral digital scanner and extra-oral digital scanner
intra-oral and extra-oral digital scanners used to obtain digital models

Experimental: extra-oral scanning of the plaster model obtained via alginate Device: intra-oral digital scanner and extra-oral digital scanner
intra-oral and extra-oral digital scanners used to obtain digital models

Experimental: extra-oral scanning of plaster model obtained via rubber base Device: intra-oral digital scanner and extra-oral digital scanner
intra-oral and extra-oral digital scanners used to obtain digital models

Experimental: extra-oral scanning of the rubber base impression Device: intra-oral digital scanner and extra-oral digital scanner
intra-oral and extra-oral digital scanners used to obtain digital models

Experimental: extra-oral scanning of the alginate impression Device: intra-oral digital scanner and extra-oral digital scanner
intra-oral and extra-oral digital scanners used to obtain digital models




Primary Outcome Measures :
  1. diagnostic accuracy [ Time Frame: 6 months ]
    evaluation of the accuracy of digital models obtained using scanners



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patients seeking orthodontic treatment permanent dentition

Exclusion Criteria:

  • deciduous or mixed dentition cleft lip and palate patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103802


Contacts
Contact: Mohamed A Labib, DDS 00201222144339 mohamedlabib90@hotmail.com

Locations
Egypt
Faculty of Dentistry- Cairo University Recruiting
Cairo Governorate, Cairo, Egypt, 12613
Contact: Mohamed A Labib, DDS         
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Khaled Hazem, PHD Cairo University

Responsible Party: Moahmed Amr Labib, Intern Student, Cairo University
ClinicalTrials.gov Identifier: NCT03103802     History of Changes
Other Study ID Numbers: CEBD-CU-2017-03-24
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No