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Completed

NCT Number: NCT05790148

Precision of Three Different Scanbodies Used for Direct Digitalization Technique

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.

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Key information

Conditions

Prosthesis User Digitalism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, Altındağ, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Clinical fit

    Time frame: 1 year

    Compatibility between the manufactured restorations and implant

    0: incompatible

    1: compatible

  2. occlusal contact

    Time frame: 1 year

    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.

  3. interface contact

    Time frame: 1 year

    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.

  4. Analytical measurement of 3D implant positions

    Time frame: 1 year

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

Secondary outcomes

  1. Visual analog scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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