Precision of Three Different Scanbodies Used for Direct Digitalization Technique

Not Applicable

Completed

• Conditions: Digitalism; Prosthesis User
• Interventions: Device: 3Shape

• Registration Number: NCT05790148
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2020-08-11
• Primary Completion: 2021-12-11
• Study Completion: 2022-06-11
• Study First Submitted: 2022-12-19
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation precision of different scan-bodies	3Shape	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.

Primary Outcome Measures

Name	Time	Method
Clinical fit	1 year	Compatibility between the manufactured restorations and implant; 0: incompatible; 1: compatible
interface contact	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.
occlusal contact	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.
Analytical measurement of 3D implant positions	1 year	Analytical outcomes were obtained from scan bodies using reverse engineering software used to calculate 3D implant positions.

Secondary Outcome Measures

Name	Time	Method
Visual analog scale	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.

Trial Locations

Locations (1)

Hacettepe University Faculty of Dentistry Department of Prosthodontics; 🇹🇷 Ankara, Altındağ, Turkey