Repetition Improves Precision and Trueness of Digital Intraoral Scans

Tooth Diseases Clinical Trial

Official title:

Standardization of Evaluation Protocol for the Performance Comparison of Digital Intra-oral Scanners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868957
• Other study ID #: ECT14-02A-27
• Secondary ID: 10053907NRF-2013
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 15, 2016
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: Seoul National University Gwanak Dental Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Study Participants: This study was approved by the institutional review board of Ehwa Womans University Medical Center Mokdong Hospital, and dental hygienists who were suitable for the purpose of the study were selected (ECT14-02A-27). Participants were assigned one of four patients, and subsequently scanned the oral cavity of a single patient 10 times repeatedly over 4 days.

Study Design: The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of two types of intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner. On the first day, either of the two types of scanners (iTero and Trios), and a patient were assigned. Then, the participants were trained in theory and practices of the assigned scanner, and subsequently, using it, scanned the dental arch of the assigned patient twice. On the second and third days, the dental arch of the same patient was scanned 3 times respectively, and on the fourth day, the experiment was finished after scanning the same patient twice.

Statistical Analyses: Collected data were analyzed using the SPSS Ver. 20.0 statistical package. For the determination of differences in the deviations according to the scanner, the independent two-sample t-test was conducted to examine the significance of the precision data. For comparisons of trueness according to repeated learning, the repeated measure ANOVA was used to test for differences between the scanners, clinical experience of the participants, and the scanning region within the same scanner group. The significance of time-dependent changes, and the interaction between the scanner group and time variables, were examined by within-subject tests. Differences between the scanner groups were examined by between-subject tests. The significance of the 10 consecutive scans and four visits within the scanner group, and the difference between the scanner groups at each time point, were examined by the post-hoc test, which was performed using the Bonferroni method as a multiple comparison (α= 0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Other:
• impression data from reference scanner
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.

Device:
• iTero
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.
• Trios
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. .

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Gwanak Dental Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Gwanak Dental Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Scan time required for full arch image acquisition in seconds	Scan time was measured until the scanned image was satisfactory with reference to the standard quality by one inspector.	up to one year	Yes