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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02364414
Enrollment
22
Registered
2015-02-18
Start date
2014-12-31
Completion date
2015-08-31
Last updated
2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital, Intra-oral Scanning, Measurements, Orthodontics, Study Models, Three Dimensional

Brief summary

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.

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.

Interventions

DEVICE3Shape TRIOS (R)

Direct intra-oral scan of teeth and dentition

Sponsors

University College, London
CollaboratorOTHER
Kettering General Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widthsWithin six weeks of initial interventionAll 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

MeasureTime frameDescription
Costwithin 6 months of initial interventionTo determine the difference in cost between the two systems

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026