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Repetition Improves Precision and Trueness of Digital Intraoral Scans

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868957
Enrollment
20
Registered
2016-08-16
Start date
2014-01-31
Completion date
2014-10-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Diseases

Keywords

CAD, Digital imaging, Prosthetic Dentistry

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).

Interventions

OTHERimpression 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.

DEVICEiTero

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.

DEVICETrios

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. .

Sponsors

Seoul National University Gwanak Dental Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Precision and trueness of intraoral scanners after repeated scanning practice assessed by Geomagic Verify Ver.20152.0One yearAssessment was done by registering pairs of scan images and calculating deviation by computer calculation in micrometers.

Secondary

MeasureTime frameDescription
Scan time required for full arch image acquisition in secondsup to one yearScan time was measured until the scanned image was satisfactory with reference to the standard quality by one inspector.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026