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

NCT02364414 | Completed

• 1 other identifier: Rdb394 v6.1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost

  within 6 months of initial intervention

Study Arms (1)

Cohort

OTHER

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)

Interventions

3Shape TRIOS (R) DEVICE

Direct intra-oral scan of teeth and dentition

Cohort

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients under 11 years old and over 18 years old.
• Carious teeth or teeth with significantly altered anatomy.
• Periodontal disease with significant gingival swelling.

Sponsors & Collaborators

• Kettering General Hospital NHS Foundation Trust: lead
• University College, London: collaborator

Study Sites (1)

Kettering General Hospital NHS Foundation Trust

Kettering, Northamptonshire, NN16 8UZ, United Kingdom

Location

Related Publications (17)

• 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.

  PMID: 12867904 BACKGROUND

• 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.

  PMID: 1877545 BACKGROUND

• 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.

  PMID: 15898364 BACKGROUND

• 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.

  PMID: 21205164 BACKGROUND

• 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.

  PMID: 22920696 BACKGROUND

• 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.

  PMID: 14530419 BACKGROUND

• 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.

  PMID: 18092365 BACKGROUND

• 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.

  PMID: 2008899 BACKGROUND

• 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.

  PMID: 11605868 BACKGROUND

• 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.

  PMID: 12828439 BACKGROUND

• 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.

  PMID: 15264638 BACKGROUND

• 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.

  PMID: 19075377 BACKGROUND

• 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.

  PMID: 16214623 BACKGROUND

• 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.

  PMID: 19358372 BACKGROUND

• 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.

  PMID: 22858338 BACKGROUND

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

  PMID: 20572526 BACKGROUND

• 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.

  PMID: 2277979 BACKGROUND

Study Officials

• Julian O'Neill, BDS FFDRCS MOrth

  Kettering General Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 18, 2015
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

GB (1)