Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study

Last updated: November 8, 2023
Sponsor: Neodent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Cobalt-Chromium (CoCr) prosthetic abutments

Clinical Study ID

NCT05649085
CS.O.013
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age
  • Patients who had GM dental implants from JJGC installed at the ILAPEO College, between 2018 and 2022
  • Patients who are using a healing abutment or cover screw and are able to installsingle-unit, screwed or cemented prostheses, in the maxilla or mandible, which requireabutments with greater transmucosal height (due to reduced interocclusal height and/orbone loss)
  • Patients presenting antagonist teeth to the implant region

Exclusion

Exclusion Criteria:

  • Patients presenting contraindications according to the IFU (instructions for use)
  • Patients who require the installation of more than 3 single-unit prostheses with CoCrabutments.

Study Design

Total Participants: 167
Treatment Group(s): 1
Primary Treatment: Cobalt-Chromium (CoCr) prosthetic abutments
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
July 31, 2025

Study Description

The cobalt-chromium prosthetic abutments are designed to be installed between the implant and prosthesis. CoCr abutment coping, CoCr abutment for crown set, block and CARES® are devices with indication for prostheses.

Data from the scientific literature support the safety and intended performance of these abutments. An observational clinical study design was chosen to augment the clinical data derived from the use of these devices in accordance with the IFU (Instruction for Use) in the daily clinical practice setting, as well as to assess the long-term prosthetic survival rate.

Connect with a study center

  • Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

    Curitiba,
    Brazil

    Active - Recruiting

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