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

Orthodontics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364414
• Other study ID #: Rdb394 v6.1
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: September 23, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Kettering General Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Device:
• 3Shape TRIOS (R)
Direct intra-oral scan of teeth and dentition

Locations

Country	Name	City	State
United Kingdom	Kettering General Hospital NHS Foundation Trust	Kettering	Northamptonshire

Sponsors (2)

Lead Sponsor	Collaborator
Kettering General Hospital NHS Foundation Trust	University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Machen DE. Legal aspects of orthodontic practice: risk management concepts. The diagnostic dilemma. Am J Orthod Dentofacial Orthop. 1991 Apr;99(4):381-2. — View Citation

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. — View Citation

Meyer BJ, Mörmann 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cost	To determine the difference in cost between the two systems	within 6 months of initial intervention	No