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NCT05649085 Clinical Trial

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

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05649085
Other study ID # CS.O.013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2023
Est. completion date July 2025

Study information
Verified date February 2023
Source Neodent
Contact Andrew Melenikiotis, MSc
Phone +55 41 3595-6000
Email amelenikiotis@uol.com.br
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 167
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO) Curitiba

Sponsors (1)
Lead Sponsor Collaborator
Neodent

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prosthesis survival arte Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments. 24 months after provisional prosthesis installation
Secondary Implant survival rate Survival rate of implant rehabilitated with prosthesis using CoCr abutments 24 months after provisional prosthesis installation
Secondary Implant success rate Success rate of implant rehabilitated with prosthesis using CoCr abutments 24 months after provisional prosthesis installation
Secondary Patient satisfaction Patient satisfaction with the treatment 24 months after provisional prosthesis installation
Secondary Clinician Satisfaction Surgeon satisfaction after the installation of the prosthesis regarding the devices used 24 months after provisional prosthesis installation
Secondary Adverse events • Occurrence of adverse events, device deficiencies and residual risks related to abutments, prostheses, and oral health. 24 months after provisional prosthesis installation
Secondary Risk factors Influence of risk factors on observed results 24 months after provisional prosthesis installation
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