Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Neodent
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- Prosthesis survival arte
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Prosthesis survival arte
Time Frame: 24 months after provisional prosthesis installation
Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.
Secondary Outcomes
- Adverse events(24 months after provisional prosthesis installation)
- Implant survival rate(24 months after provisional prosthesis installation)
- Clinician Satisfaction(24 months after provisional prosthesis installation)
- Implant success rate(24 months after provisional prosthesis installation)
- Patient satisfaction(24 months after provisional prosthesis installation)
- Risk factors(24 months after provisional prosthesis installation)