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

Dentition/Teeth Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934517
• Other study ID #: VCP2013udem
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: January 17, 2016
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Comité d'éthique de la recherche en santé (CERES)
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dentition/Teeth Measurement

Locations

Country	Name	City	State
Canada	University of Montreal, Faculty of Orthodontics	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overjet	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	one year	No