Precision of Three Different Scanbodies Used for Direct Digitalization Technique

Prosthesis User Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790148
• Other study ID #: KA-19091
• Status: Completed
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: June 11, 2022

Study information

• Verified date: March 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 have short edentulous span in posterior region that will receive implant-supported prostheses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 11, 2022
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis User

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Dentistry Department of Prosthodontics	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical fit	Compatibility between the manufactured restorations and implant; 0: incompatible; 1: compatible	1 year
Primary	occlusal contact	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.	1 year
Primary	interface contact	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.	1 year
Primary	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	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.	1 year