Precision of Three Different Scanbodies Used for Direct Digitalization Technique

March 27, 2023 updated by: Kıvanç Akça, Hacettepe University

Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant Supported Fixed Prosthesis: A Methodologic Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06230
        • Hacettepe University Faculty of Dentistry Department of Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical fit
Time Frame: 1 year

Compatibility between the manufactured restorations and implant

0: incompatible

1: compatible
1 year
occlusal contact
Time Frame: 1 year

Restoration occlusal contact with the opposite teeth.

I.Occlusal Contacts:

  1. Perfect: No need for occlusal contact adjustment,
  2. Acceptable: Minor occlusal contact adjustment is needed,
  3. Correction needed: Major occlusal contact adjustment is needed.
1 year
interface contact
Time Frame: 1 year

Restoration interface contacts with the adjacent teeth.

II. Interface Contacts:

  1. Perfect: The floss is inserted into the interdental space only under pressure,
  2. Acceptable (1): The contact is slightly tight but the floss is placed under pressure,
  3. Acceptable (2): The contact is slightly weak, the floss is placed in one stroke without applying pressure,
  4. Correction required: Contact is poor and 100 μm metal sheet passes easily.
1 year
Analytical measurement of 3D implant positions
Time Frame: 1 year
Analytical outcomes were obtained from scan bodies using reverse engineering software used to calculate 3D implant positions.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2020

Primary Completion (Actual)

December 11, 2021

Study Completion (Actual)

June 11, 2022

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA-19091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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