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

September 23, 2015 updated by: Kettering General Hospital NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • United Kingdom
    • Northamptonshire
      • Kettering, Northamptonshire, United Kingdom, NN16 8UZ
        • Kettering General Hospital NHS Foundation Trust

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

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort
Orthodontic patients, aged 11-18 who fulfill the inclusion/exclusion criteria and provide written informed consent to participate will undergo intra-oral scan. This will be repeated 2 weeks later.
Device: 3Shape TRIOS (R)
Direct intra-oral scan of teeth and dentition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within six weeks of initial intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: within 6 months of initial intervention
To determine the difference in cost between the two systems
within 6 months of initial intervention

Collaborators and Investigators

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

Sponsor

Kettering General Hospital NHS Foundation Trust

Collaborators

University College, London

Investigators

  • Principal Investigator: Julian O'Neill, BDS FFDRCS MOrth, Kettering General Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Rdb394 v6.1

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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