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

NCT ID: NCT05649085

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Missing Teeth Prosthesis Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cobalt-Chromium (CoCr) prosthetic abutments

Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses

Intervention Type DEVICE

Eligibility Criteria

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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 install single-unit, screwed or cemented prostheses, in the maxilla or mandible, which require abutments with greater transmucosal height (due to reduced interocclusal height and/or bone loss)
* Patients presenting antagonist teeth to the implant region

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 CoCr abutments.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neodent

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Waleska Caldas

Role: STUDY_DIRECTOR

Neodent

Locations

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Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Andrew Melenikiotis, MSc

Role: CONTACT

+55 41 3595-6000

Facility Contacts

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Andrew Sotirios Melenekiotis

Role: primary

Other Identifiers

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CS.O.013

Identifier Type: -

Identifier Source: org_study_id

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