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Prosthesis UserNCT05790148

Precision of Three Different Scanbodies Used for Direct Digitalization Technique

A study testing 3Shape in people with Prosthesis User and Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prosthesis User, Digitalism
What is being tested?
3Shape
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
11 Aug 2020to 11 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University Faculty of Dentistry Department of Prosthodontics

    Ankara, Altındağ, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
3Shape
Keywords
digital dentistry, intraoral scanner, implant scanbody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3ShapeDevice

    Also called Straumann (CARES Mono Scanbody; Straumann Holding AG), Medentika (Scanbody 2.generation; MEDENTIKA GmbH, Hügelsheim, Germany) , 3Shape (3Shape A/S, Copenhagen, Denmark)

    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.

Study groups in NCT05790148
Study groupRoleWhat they receive
Evaluation precision of different scan-bodiesOtherThree 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.
Receives: Device: 3Shape

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical fit

    Compatibility between the manufactured restorations and implant

    0: incompatible

    1: compatible

    Measured: 1 year

  2. occlusal contact

    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.

    Measured: 1 year

  3. interface contact

    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.

    Measured: 1 year

  4. Analytical measurement of 3D implant positions

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

    Measured: 1 year

Secondary outcomes (1)

  1. Visual analog scale

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start11 Aug 2020
  3. Primary completion11 Dec 2021
  4. Study completion11 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05790148
Sponsor's protocol ID
KA-19091
Status last verified
Mar 2023
First submitted
19 Dec 2022
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oh KC, Park JM, Moon HS. Effects of Scanning Strategy and Scanner Type on the Accuracy of Intraoral Scans: A New Approach for Assessing the Accuracy of Scanned Data. J Prosthodont. 2020 Jul;29(6):518-523. doi: 10.1111/jopr.13158. Epub 2020 Jun 26.

    PubMed 32133690

  • Passos L, Meiga S, Brigagao V, Street A. Impact of different scanning strategies on the accuracy of two current intraoral scanning systems in complete-arch impressions: an in vitro study. Int J Comput Dent. 2019;22(4):307-319.

    PubMed 31840139

Questions about this trial

What is this clinical trial studying?

A study testing 3Shape in people with Prosthesis User and Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical fit (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05790148, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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