Precision of Three Different Scanbodies Used for Direct Digitalization Technique

NCT05790148 | Completed

• 1 other identifier: KA-19091
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis User; Digitalism

Keywords

digital dentistry; intraoral scanner; implant scanbody

Outcome Measures

Primary Outcomes (4)

• Clinical fit

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

  1 year

• 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.

  1 year

• 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.

  1 year

• Analytical measurement of 3D implant positions

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

  1 year

Secondary Outcomes (1)

• Visual analog scale

  1 year

Study Arms (1)

Evaluation precision of different scan-bodies

OTHER

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

Interventions

3Shape 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.

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

Evaluation precision of different scan-bodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32133690 RESULT

• 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.

  PMID: 31840139 RESULT

Study Officials

• Fatmanur Demir, DDS

  Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: March 30, 2023
• Study Start: August 11, 2020
• Primary Completion: December 11, 2021
• Study Completion: June 11, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)