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OpenTrials
Completed

NCT Number: NCT01934517

Validity of Digital Models Obtained With iTero® and Lava Digital® 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.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Montreal, Faculty of Orthodontics

Montreal, Quebec, H3V1H9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2013
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.