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

January 17, 2016 updated by: Normand Bach, Université de Montréal

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3V1H9
        • University of Montreal, Faculty of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring an orthodontic treatment from the Orthodontics clinic of the University of Montreal

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: Vincent-Claude Peloquin, resident, University of Montreal, department of Orthodontics
  • Study Director: Normand Bach, D.M.D., M.Sc., F.R.C.D.(c), Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

January 17, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • VCP2013udem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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