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

Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)

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

Study Overview

• Status: Unknown
• Conditions: Orthodontics
• Intervention / Treatment: Device: intra-oral digital scanner and extra-oral digital scanner

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 12613
      • Recruiting
      • Faculty of Dentistry- Cairo University
      • Contact: Mohamed A Labib, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients seeking orthodontic treatment permanent dentition

Exclusion Criteria:

• deciduous or mixed dentition cleft lip and palate patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy	evaluation of the accuracy of digital models obtained using scanners	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Khaled Hazem, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2017
• Primary Completion (Anticipated): October 30, 2017
• Study Completion (Anticipated): February 27, 2018

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 1, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2017-03-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No