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Repetition Improves Precision and Trueness of Digital Intraoral Scans

Primary Purpose

Tooth Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
impression data from reference scanner
iTero
Trios
Sponsored by
Seoul National University Gwanak Dental Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tooth Diseases focused on measuring CAD, Digital imaging, Prosthetic Dentistry

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Gwanak Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Impression data from reference scanner

Trios

iTero

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 9, 2016
Last Updated
August 15, 2016
Sponsor
Seoul National University Gwanak Dental Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02868957
Brief Title
Repetition Improves Precision and Trueness of Digital Intraoral Scans
Official Title
Standardization of Evaluation Protocol for the Performance Comparison of Digital Intra-oral Scanners
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Gwanak Dental Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
CAD, Digital imaging, Prosthetic Dentistry

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impression data from reference scanner
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trios
Arm Type
Experimental
Arm Description
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.
Arm Title
iTero
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
impression data from reference scanner
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
iTero
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Trios
Intervention Description
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. .
Primary Outcome Measure Information:
Title
Precision and trueness of intraoral scanners after repeated scanning practice assessed by Geomagic Verify Ver.20152.0
Description
Assessment was done by registering pairs of scan images and calculating deviation by computer calculation in micrometers.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Scan time required for full arch image acquisition in seconds
Description
Scan time was measured until the scanned image was satisfactory with reference to the standard quality by one inspector.
Time Frame
up to one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Man Park, PhD
Organizational Affiliation
Seoul National University Gwanak Dental Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Gwanak Dental Hospital
City
Seoul
ZIP/Postal Code
08826
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The three dimensional data in .stl format and the time required for the full arch intra-oral scan of the patient will be provided. These data can be provided after the approval of uploaded documents for our clinical trial. The data can be provided via shared files to the individuals who want IPD in this study.
Citations:
PubMed Identifier
22353208
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.
Results Reference
background
PubMed Identifier
23641661
Citation
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.
Results Reference
background
PubMed Identifier
19628099
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.
Results Reference
background
PubMed Identifier
24479892
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.
Results Reference
background
PubMed Identifier
24878708
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.
Results Reference
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Repetition Improves Precision and Trueness of Digital Intraoral Scans

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