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

Recruiting

• Conditions: Missing Teeth; Prosthesis Survival

• Registration Number: NCT05649085
• Lead Sponsor: Neodent

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Status Verified: 2023-02
• Study Start: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 167

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prosthesis survival arte	24 months after provisional prosthesis installation	Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 months after provisional prosthesis installation	• Occurrence of adverse events, device deficiencies and residual risks related to abutments, prostheses, and oral health.
Implant survival rate	24 months after provisional prosthesis installation	Survival rate of implant rehabilitated with prosthesis using CoCr abutments
Clinician Satisfaction	24 months after provisional prosthesis installation	Surgeon satisfaction after the installation of the prosthesis regarding the devices used
Implant success rate	24 months after provisional prosthesis installation	Success rate of implant rehabilitated with prosthesis using CoCr abutments
Patient satisfaction	24 months after provisional prosthesis installation	Patient satisfaction with the treatment
Risk factors	24 months after provisional prosthesis installation	Influence of risk factors on observed results

Trial Locations

Locations (1)

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO); 🇧🇷 Curitiba, Brazil