Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant Supported Fixed Prosthesis: A Methodologic Clinical Study
Phase: NA
Conditions: Prosthesis User, Digitalism
Sponsor: Hacettepe University

10.10.2022 
 
Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant 
Supported Fixed Prosthesis: A Methodologic Clinical Study. 
 
Study Protokol: The study design was planned to comply with the CONSORT (Consolidated 
Standards of Reporting Trials; http://www.consort statement.org/about-consort) and STARD 
(Enhancing the Quality and Transparency of Health Research; http://www.equator 
network.org) reporting guidelines for clinical trials. In this methodological clinical study, the 
precision of three different scan-bodies used for the full digital workflow production of the 
same fixed prostheses with two implants was comparatively evaluated in the clinical and virtual 
environment. Three scan-bodies used; Group-I: one original scanning post produced by the 
manufacturer of the dental implant (CARES Mono Scanbody; Straumann Holding AG), Group 
II: non-original produced by 2 different manufacturers compatible with the dental implant 
(Scanbody 2.generation; MEDENTIKA GmbH, Hügelsheim,Germany) and generic (3Shape 
Scanbody, 3Shape A/S) scan posts. Randomization was applied using a free-access internet-
based application (Research Randomizer; http://www.randomizer.org) to determine the order 
of the scan-bodies, and the direct digitalization process of three different scan-bodies was 
completed in a single session for the same fixed prostheses production in accordance with the 
specified order. Then, the restorations designed in the CAD step were transferred to the CAM 
unit and produced without a model in the form of a full contour using the subtractive technique. 
Primary data were obtained by the qualitative evaluation of the restorations in the clinic, and 
secondary data were obtained by analyzing the scan post surface data obtained with direct 
digitalization using the "reverse engineering" process. With these data, the precision of Group 
I and Group II scan-bodies was evaluated comparatively. This study was accepted by the 
Hacettepe University Clinical Research Ethics Committee (protocol code: KA-19091) and was 
approved by the Ministry of Health, Turkish Medicines and Medical Devices Agency. (No: 
E.471606) The patients were informed in detail about the procedures to be applied and their 
participation was ensured by signing the informed consent form. No additional fee was 
requested from the patients. The study was partially supported by Hacettepe University 
Scientific Research Projects Coordination Unit (project no: 18710). The intraoral scanner 
3Shape TRIOS3 (3Shape A/S) was supplied by 3Shape Middle East & Turkey. 
 

Sample Size and Power Analysis: In order to optimize the data to be obtained in the study at 
the desired effect level, the analyzes were performed using the Repeated Measures Anova 
method. The sample size for the restorations to be included was calculated using the same 
method, in order to significantly determine the effect width of 0.33 units (partial eta-
squared=0.10) at 80% power and 5% type 1 error level, and it was decided to include at least 
25 volunteers in the study. Power analysis calculations were made using G*Power 3.1 software. 
 
Statistical Analysis: Statistical data analysis in terms of lower/upper jaw location of different 
scan posts and fixed prosteheses, which are thought to be important on quantitative and 
qualitative data, was performed with Chi-square test using IBM SPSS 23 software. The 
conformity of quantitative variables to normal distribution was examined using the Shapiro-
Wilk test of normality. Mean and standard deviation were used as descriptive statistics for 
quantitative variables with normal distribution, and median, smallest, largest and interquartile 
range values were used for non-normally distributed variables. Qualitative variables were 
defined with numbers and percentages. In terms of quantitative measurements, comparisons 
between groups were used in cases where parametric test conditions were met (conformity to 
normal distribution). Statistical significance level was determined as 0.05 in the study.