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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Prosthesis Failure
• Prosthesis Survival
• Tooth Loss

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