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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Device: 3Shape TRIOS (R)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort<br>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)<br>* Direct intra-oral scan of teeth and dentition<br>|

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 | 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 | To determine the difference in cost between the two systems | within 6 months of initial intervention |