Precision of Three Different Scanbodies Used for Direct Digitalization Technique

NCT ID: NCT05790148

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2022-06-11

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.

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.

Conditions

Prosthesis User; Digitalism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

3Shape

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kıvanç Akça

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatmanur Demir, DDS

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey

Locations

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 32133690 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31840139 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KA-19091

Identifier Type: -

Identifier Source: org_study_id