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

Completed

• Conditions: Dentition/Teeth Measurement

• Registration Number: NCT01934517
• Lead Sponsor: Université de Montréal

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2014-05
• Study Completion: 2015-06
• Results First Submitted: 2015-06-01
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-17
• Last Update Submitted: 2016-01-17
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overjet	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

Trial Locations

Locations (1)

University of Montreal, Faculty of Orthodontics; 🇨🇦 Montreal, Quebec, Canada