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

NCT ID: NCT02364414

Last Updated: 2015-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Orthodontics Study Models Intra-oral Scanning Measurements Digital Three Dimensional

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

3Shape TRIOS (R)

Intervention Type DEVICE

Direct intra-oral scan of teeth and dentition

Interventions

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3Shape TRIOS (R)

Direct intra-oral scan of teeth and dentition

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

Kettering General Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julian O'Neill, BDS FFDRCS MOrth

Role: PRINCIPAL_INVESTIGATOR

Kettering General Hospital NHS Foundation Trust

Locations

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Kettering General Hospital NHS Foundation Trust

Kettering, Northamptonshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Santoro M, Galkin S, Teredesai M, Nicolay OF, Cangialosi TJ. Comparison of measurements made on digital and plaster models. Am J Orthod Dentofacial Orthop. 2003 Jul;124(1):101-5. doi: 10.1016/s0889-5406(03)00152-5.

Reference Type BACKGROUND
PMID: 12867904 (View on PubMed)

Han UK, Vig KW, Weintraub JA, Vig PS, Kowalski CJ. Consistency of orthodontic treatment decisions relative to diagnostic records. Am J Orthod Dentofacial Orthop. 1991 Sep;100(3):212-9. doi: 10.1016/0889-5406(91)70058-5.

Reference Type BACKGROUND
PMID: 1877545 (View on PubMed)

Rheude B, Sadowsky PL, Ferriera A, Jacobson A. An evaluation of the use of digital study models in orthodontic diagnosis and treatment planning. Angle Orthod. 2005 May;75(3):300-4. doi: 10.1043/0003-3219(2005)75[300:AEOTUO]2.0.CO;2.

Reference Type BACKGROUND
PMID: 15898364 (View on PubMed)

Fleming PS, Marinho V, Johal A. Orthodontic measurements on digital study models compared with plaster models: a systematic review. Orthod Craniofac Res. 2011 Feb;14(1):1-16. doi: 10.1111/j.1601-6343.2010.01503.x. Epub 2010 Nov 22.

Reference Type BACKGROUND
PMID: 21205164 (View on PubMed)

Cuperus AM, Harms MC, Rangel FA, Bronkhorst EM, Schols JG, Breuning KH. Dental models made with an intraoral scanner: a validation study. Am J Orthod Dentofacial Orthop. 2012 Sep;142(3):308-13. doi: 10.1016/j.ajodo.2012.03.031.

Reference Type BACKGROUND
PMID: 22920696 (View on PubMed)

Bell A, Ayoub AF, Siebert P. Assessment of the accuracy of a three-dimensional imaging system for archiving dental study models. J Orthod. 2003 Sep;30(3):219-23. doi: 10.1093/ortho/30.3.219.

Reference Type BACKGROUND
PMID: 14530419 (View on PubMed)

Lee SP, Delong R, Hodges JS, Hayashi K, Lee JB. Predicting first molar width using virtual models of dental arches. Clin Anat. 2008 Jan;21(1):27-32. doi: 10.1002/ca.20580.

Reference Type BACKGROUND
PMID: 18092365 (View on PubMed)

Machen DE. Legal aspects of orthodontic practice: risk management concepts. The diagnostic dilemma. Am J Orthod Dentofacial Orthop. 1991 Apr;99(4):381-2. doi: 10.1016/s0889-5406(05)81419-2. No abstract available.

Reference Type BACKGROUND
PMID: 2008899 (View on PubMed)

Tomassetti JJ, Taloumis LJ, Denny JM, Fischer JR Jr. A comparison of 3 computerized Bolton tooth-size analyses with a commonly used method. Angle Orthod. 2001 Oct;71(5):351-7. doi: 10.1043/0003-3219(2001)0712.0.CO;2.

Reference Type BACKGROUND
PMID: 11605868 (View on PubMed)

Zilberman O, Huggare JA, Parikakis KA. Evaluation of the validity of tooth size and arch width measurements using conventional and three-dimensional virtual orthodontic models. Angle Orthod. 2003 Jun;73(3):301-6. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

Reference Type BACKGROUND
PMID: 12828439 (View on PubMed)

Quimby ML, Vig KW, Rashid RG, Firestone AR. The accuracy and reliability of measurements made on computer-based digital models. Angle Orthod. 2004 Jun;74(3):298-303. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

Reference Type BACKGROUND
PMID: 15264638 (View on PubMed)

Keim RG, Gottlieb EL, Nelson AH, Vogels DS 3rd. 2008 JCO study of orthodontic diagnosis and treatment procedures, part 1: results and trends. J Clin Orthod. 2008 Nov;42(11):625-40. No abstract available.

Reference Type BACKGROUND
PMID: 19075377 (View on PubMed)

Mayers M, Firestone AR, Rashid R, Vig KW. Comparison of peer assessment rating (PAR) index scores of plaster and computer-based digital models. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):431-4. doi: 10.1016/j.ajodo.2004.04.035.

Reference Type BACKGROUND
PMID: 16214623 (View on PubMed)

Pani SC, Hedge AM. Impressions in cleft lip and palate--a novel two stage technique. J Clin Pediatr Dent. 2008 Winter;33(2):93-6.

Reference Type BACKGROUND
PMID: 19358372 (View on PubMed)

Sousa MV, Vasconcelos EC, Janson G, Garib D, Pinzan A. Accuracy and reproducibility of 3-dimensional digital model measurements. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):269-73. doi: 10.1016/j.ajodo.2011.12.028.

Reference Type BACKGROUND
PMID: 22858338 (View on PubMed)

Kachalia PR, Geissberger MJ. Dentistry a la carte: in-office CAD/CAM technology. J Calif Dent Assoc. 2010 May;38(5):323-30.

Reference Type BACKGROUND
PMID: 20572526 (View on PubMed)

Meyer BJ, Mormann WH, Lutz F. [Optimization of the powder application in the Cerec method with environment-friendly propellant systems]. Schweiz Monatsschr Zahnmed. 1990;100(12):1462-8. German.

Reference Type BACKGROUND
PMID: 2277979 (View on PubMed)

Other Identifiers

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Rdb394 v6.1

Identifier Type: -

Identifier Source: org_study_id

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