Precision of Three Different Scanbodies Used for Direct Digitalization Technique

Hacettepe University (Other)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is:

  1. Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses?

Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.

Condition or Disease Intervention/Treatment Phase
  • Device: 3Shape

Detailed Description

Twenty-five patients receiving two implant supported restorations in treatment of short-span partial edentulism were enrolled into the study. Three different scanbodies, original, non-original and generic, were employed for direct digitalization technique. Full contour PMMA restorations were CAD/CAM fabricated from each digital record, and were evaluated in terms of implant fit, axial- and occlusal-contact. Additionally, patient's impressions for digitalization and delivery procedures were recorded using a visual analog scale. Scanbody scan recordings were subjected to reverse engineering for analytical evaluation of 3D virtual implant positioning.

Study Design

Study Type:
Actual Enrollment :
25 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Masking Description:
Scan post information used for direct digitalization was not shared with the patient during the procedure. The investigator, who performed the statistical analysis, did not learn the scan post, in which the primary and secondary data were collected, until all evaluations were completed.
Primary Purpose:
Official Title:
Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant Supported Fixed Prosthesis: A Methodologic Clinical Study
Actual Study Start Date :
Aug 11, 2020
Actual Primary Completion Date :
Dec 11, 2021
Actual Study Completion Date :
Jun 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Evaluation precision of different scan-bodies

Three different brand scanbodies (Straumann, Medentika, 3Shape) that applied in same participant group with randomization are used in this clinical study. These three different scan bodies are digitized using an intraoral scanner. Three different temporary restorations are designed in the CAD program and three different bridges are produced with the milling technique using the temporary restoration block. Clinical and analytic evaluations were perform and primarly, seconderly outcomes were achieved.

Device: 3Shape
original (Straumann), non-original (Medentika) and generic scan-bodies (3Shape) were utilized for direct digitalization using intraoral scanner with image stitching algorithm. Full contour temporary restorations were fabricated from each digital record, and were evaluated in terms of clinical and analytical.
Other Names:
  • Straumann (CARES Mono Scanbody; Straumann Holding AG), Medentika (Scanbody 2.generation; MEDENTIKA GmbH, Hügelsheim, Germany) , 3Shape (3Shape A/S, Copenhagen, Denmark)
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical fit [1 year]

      Compatibility between the manufactured restorations and implant 0: incompatible 1: compatible

    2. occlusal contact [1 year]

      Restoration occlusal contact with the opposite teeth. I.Occlusal Contacts: Perfect: No need for occlusal contact adjustment, Acceptable: Minor occlusal contact adjustment is needed, Correction needed: Major occlusal contact adjustment is needed.

    3. interface contact [1 year]

      Restoration interface contacts with the adjacent teeth. II. Interface Contacts: Perfect: The floss is inserted into the interdental space only under pressure, Acceptable (1): The contact is slightly tight but the floss is placed under pressure, Acceptable (2): The contact is slightly weak, the floss is placed in one stroke without applying pressure, Correction required: Contact is poor and 100 μm metal sheet passes easily.

    4. Analytical measurement of 3D implant positions [1 year]

      Analytical outcomes were obtained from scan bodies using reverse engineering software used to calculate 3D implant positions.

    Secondary Outcome Measures

    1. Visual analog scale [1 year]

      Patient impression was done in two clinical stages, registration and restoration delivery, and a scale of five points from 0 to 100 was used. A value of 0 is set to be straightforward and 100 complex. During the registration phase, the patient's anxiety level about the direct digitalization procedure, which was explained in detail before registration, was determined. After the registration, it was asked to evaluate the difficulty of the process. The time spent for adjustment during the restoration delivery phase and the comfort feeling of the restoration after adjustment were evaluated.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Be willing to voluntarily participate in the study after reading the informed consent form.

    • Adult patient over 18 years of age who has completed growth and development

    • Partial edentulism in the functional region for a two-implant-supported restoration with two or three occlusal members

    • Having a fixed dentition in the opposing arch

    • The occlusal relationship between the jaws does not require vertical and horizontal prosthetic treatment.

    • Having bone-level implants placed with "straightforward" surgery according to the SAC classification system [248] and without advanced surgical technique

    Exclusion Criteria:
    • Not voluntarily agreeing to participate in the study after reading the informed consent form

    • Having one or more of the conditions for which implant treatment is strictly contraindicated (patients who have received radiation therapy, bone cancer, metabolic disorders)

    • Having systemic (steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) risk factors for implant treatment

    • Having local (periodontal discomfort, bruxism, poor oral hygiene) risk factors for implant treatment

    Contacts and Locations


    Site City State Country Postal Code
    1 Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara Altındağ Turkey 06230

    Sponsors and Collaborators

    • Hacettepe University


    • Principal Investigator: Fatmanur Demir, DDS, Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey

    Study Documents (Full-Text)

    More Information


    None provided.
    Responsible Party:
    Kıvanç Akça, Prof. Dr., Hacettepe University Identifier:
    Other Study ID Numbers:
    • KA-19091
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Kıvanç Akça, Prof. Dr., Hacettepe University

    Study Results

    No Results Posted as of Mar 30, 2023