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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01934517
Study type Observational
Source Université de Montréal
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date June 2015