NCT05649085

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 167 (estimated)
• Sponsor: Neodent · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Missing Teeth
• Prosthesis Survival

Interventions

Type	Name	Description
DEVICE	Cobalt-Chromium (CoCr) prosthetic abutments	Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-12-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study