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

Neodent

Status: Enrolling

Conditions: Missing Teeth; Prosthesis Survival

Treatments: Device: Cobalt-Chromium (CoCr) prosthetic abutments

Study type: Observational

Funder types: Industry

Identifiers

NCT05649085

CS.O.013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.