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Completed

NCT Number: NCT02364414

The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models

The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.

The investigators will test the hypotheses:

* There is no systematic difference between measurements taken from the Trios scanner and study models. * There is no difference in the cost of producing digital models.

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Key information

Conditions

Orthodontics Digital Intra-oral Scanning Measurements Study Models Three Dimensional

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kettering General Hospital NHS Foundation Trust

Kettering, Northamptonshire, NN16 8UZ, United Kingdom

About this study

Plaster study models produced from moulds of the teeth are a standard component of orthodontic records. They are fundamental to diagnosis and treatment planning, evaluation of treatment progress and results as well as record keeping. (Santoro et al., 2003) Plaster models must be retained for a minimum of 11 years for a medico legal reasons. This leads to problems of storage in terms of space and cost, in addition to the risk of damage because of the brittle nature of the models. These problems therefore highlight the need for an alternative method for producing and storing study models. This study aims to compare the accuracy of measurements derived from a new commercially available direct intra-oral (inside of the mouth) scanning system (3Shape TRIOS (R)) with those taken from plaster study models, and to compare cost implications of both systems. We will use the results to conclude whether direct intra¬oral scanning can replace traditional plaster models produced from moulds of the teeth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range 11 years old to 18 years old.
  • Orthodontic patients with a range of malocclusions.
  • Dentition without abnormal morphology.
  • Adult/permanent dentition from the first molar to first molar in both arches.

Exclusion criteria

  • Patients under 11 years old and over 18 years old.
  • Carious teeth or teeth with significantly altered anatomy.
  • Periodontal disease with significant gingival swelling.

Treatment and study plan

3Shape TRIOS (R)

Device

Direct intra-oral scan of teeth and dentition

Primary outcomes

  1. Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths

    Time frame: Within six weeks of initial intervention

    All dental study models, and 3D scans will have all the above measurements carried out. There are 22 patients and each will have had study models made and these will be measured twice on two separate occasions, and all scans measured twice.

    The measurements will be compared and analysed to see if the 3D scans accurately represent the tooth sizes and measurements that have been carried out on the dental study models (gold standard).

Secondary outcomes

  1. Cost

    Time frame: within 6 months of initial intervention

    To determine the difference in cost between the two systems

Sponsors and collaborators

Lead sponsor

Kettering General Hospital NHS Foundation Trust

Other

Collaborators

  • University College, London

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
Sep 24, 2015

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.

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