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Clinical Trials/NCT01934517
NCT01934517
Completed
Not Applicable

Validity, Reliability and Reproducibility of Digital Models Obtained With iTero® (AlignTech) and Lava Digital® (3M) in Comparison With Plaster Models.

Université de Montréal1 site in 1 country25 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dentition/Teeth Measurement
Sponsor
Université de Montréal
Enrollment
25
Locations
1
Primary Endpoint
Overjet
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.

Detailed Description

The primary objective of this study is to evaluate the validity, reliability and reproducibility of the dental measurements obtained on the digital models with iTero® in comparison with those obtained on the plaster models (gold standard) and on the digital models with Lava Digital®. The secondary objective is to compare two different impression materials (i.e. alginate and polyvinylsiloxane (PVS)) and determine whether the impression material used affects the accuracy of the measurements. Statistical analysis: * Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models. * A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS). * A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models. * Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
June 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Normand Bach

professor

Université de Montréal

Eligibility Criteria

Inclusion Criteria

  • Aged between 12 and 30 years old (male or female)
  • complete permanent dentition from first molar to the other first molar
  • no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth

Exclusion Criteria

  • Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)

Outcomes

Primary Outcomes

Overjet

Time Frame: one year

Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor

Study Sites (1)

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