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

Kettering General Hospital NHS Foundation Trust

Status: Completed

Conditions: Digital; Measurements; Orthodontics; Study Models; Intra-oral Scanning; Three Dimensional

Treatments: Device: 3Shape TRIOS (R)

Study type: Interventional

Funder types: Other

Identifiers

NCT02364414

Rdb394 v6.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Cohort

Other group

Description:

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.

Treatment:

Device: 3Shape TRIOS (R)