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

U

Université de Montréal

Status

Completed

Conditions

Dentition/Teeth Measurement

Study type

Observational

Funder types

Other

Identifiers

NCT01934517
VCP2013udem

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

12 to 30 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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