Precision of Three Different Scanbodies Used for Direct Digitalization Technique

Hacettepe University

Status: Completed

Conditions: Digitalism; Prosthesis User

Treatments: Device: 3Shape

Study type: Interventional

Funder types: Other

Identifiers

NCT05790148

KA-19091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Evaluation precision of different scan-bodies

Other group

Description:

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.

Treatment:

Device: 3Shape