Repetition Improves Precision and Trueness of Digital Intraoral Scans

NCT02868957 | Completed DMC

• 3 other identifiers: ECT14-02A-2710053907NRF-2013R1A1A1076022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study were to compare the precision of two digital intraoral scanners from a series of repeat scan images, and to investigate the effect of the learning curve on changes in trueness when scanning the full arch of the oral cavity in actual patients.

Conditions

Tooth Diseases

Keywords

CAD; Digital imaging; Prosthetic Dentistry

Outcome Measures

Primary Outcomes (1)

• Precision and trueness of intraoral scanners after repeated scanning practice assessed by Geomagic Verify Ver.20152.0

  Assessment was done by registering pairs of scan images and calculating deviation by computer calculation in micrometers.

  One year

Secondary Outcomes (1)

• Scan time required for full arch image acquisition in seconds

  up to one year

Study Arms (3)

Impression data from reference scanner

ACTIVE COMPARATOR

desktop scanner was used as a reference scanner. According to the data of the manufacturer, the accuracy is less than 20 µm and the scan points more than 100,000.

Device: iTero; Device: Trios

Trios

EXPERIMENTAL

Trios is a scanner with real time rendering type adopting the confocal principle, and scans the object while showing the scanned area on a screen. Interventions: Assigned intervention to participants in this clinical study was in the form of repetitive learning of Trios intra-oral scanner.

Other: impression data from reference scanner; Device: Trios

iTero

EXPERIMENTAL

iTero captures teeth and periodontal soft tissue using a red laser beam and parallel confocal imaging technology. This system with a focal depth of 300 can capture up to 100,000 of laser points, and each of such laser points is separated at a 50 mm gap. Interventions: Assigned intervention to participants in this clinical study was in the form of repetitive learning of iTero intra-oral scanner.

Other: impression data from reference scanner; Device: iTero

Interventions

impression data from reference scanner OTHER

To create a reference images for the assessment of the trueness, the impressions of the upper and lower arch of the oral cavities of four patients were taken using a polyether impression material (3M ESPE Soft Monophase; Minnesota Mining and Manufacturing Co.), and the intaglio scanning was performed on the impression body using a desktop scanner. Scanned images were transformed to the Standard Tessellation Language (STL) file format, and used as reference images.

Trios; iTero

iTero DEVICE

The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of iTero intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner.

Impression data from reference scanner; iTero

Trios DEVICE

The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of Trios intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner. .

Impression data from reference scanner; Trios

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The selection criteria for the participants were as follows: they had the clinical experiences between 3 - 11 years, understood the purpose of the study well, gave their consent, and were able to carry out a 4-day learning course. Those who were inadequate to carry out the study mentally or physically.

You may not qualify if:

• Applicant who was considered inappropriate .for this study by the principal investigator was excluded from the selection

Sponsors & Collaborators

• Seoul National University Gwanak Dental Hospital: lead

Study Sites (1)

Seoul National University Gwanak Dental Hospital

Seoul, Seoul, 08826, South Korea

Location

Related Publications (5)

• Lee SJ, Gallucci GO. Digital vs. conventional implant impressions: efficiency outcomes. Clin Oral Implants Res. 2013 Jan;24(1):111-5. doi: 10.1111/j.1600-0501.2012.02430.x. Epub 2012 Feb 22.

  PMID: 22353208 BACKGROUND

• Ender A, Mehl A. Influence of scanning strategies on the accuracy of digital intraoral scanning systems. Int J Comput Dent. 2013;16(1):11-21. English, German.

  PMID: 23641661 BACKGROUND

• Feldman LS, Cao J, Andalib A, Fraser S, Fried GM. A method to characterize the learning curve for performance of a fundamental laparoscopic simulator task: defining "learning plateau" and "learning rate". Surgery. 2009 Aug;146(2):381-6. doi: 10.1016/j.surg.2009.02.021. Epub 2009 Jun 25.

  PMID: 19628099 BACKGROUND

• Yuzbasioglu E, Kurt H, Turunc R, Bilir H. Comparison of digital and conventional impression techniques: evaluation of patients' perception, treatment comfort, effectiveness and clinical outcomes. BMC Oral Health. 2014 Jan 30;14:10. doi: 10.1186/1472-6831-14-10.

  PMID: 24479892 BACKGROUND

• Patzelt SB, Lamprinos C, Stampf S, Att W. The time efficiency of intraoral scanners: an in vitro comparative study. J Am Dent Assoc. 2014 Jun;145(6):542-51. doi: 10.14219/jada.2014.23.

  PMID: 24878708 BACKGROUND

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Ji-Man Park, PhD

  Seoul National University Gwanak Dental Hosipital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)