Clinical trial NCT02364414: The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models
Official title: The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Study Models
Intra-oral Scanning
Measurements
Digital
Three Dimensional
Lead sponsor: Kettering General Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2015-02-18
Enrollment: 22
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths
timeFrame: Within six weeks of initial intervention
Secondary outcomes:
measure: Cost
timeFrame: within 6 months of initial intervention
Other outcomes:
Locations:
city: Kettering
country: United Kingdom
facility: Kettering General Hospital NHS Foundation Trust
state: Northamptonshire
Study officials:
affiliation: Kettering General Hospital NHS Foundation Trust
name: Julian O'Neill, BDS FFDRCS MOrth
role: PRINCIPAL_INVESTIGATOR
References:
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