Tooth Diseases Clinical Trial
Official title:
Standardization of Evaluation Protocol for the Performance Comparison of Digital Intra-oral Scanners
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.
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).
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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