Clinical Trials Directory

Trials / Completed

CompletedNCT01934517

Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Université de Montréal · Academic / Other
Sex
All
Age
12 Years – 30 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2013-08-01
Primary completion
2014-05-01
Completion
2015-06-01
First posted
2013-09-04
Last updated
2016-02-15
Results posted
2016-02-15

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01934517. Inclusion in this directory is not an endorsement.