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

Sponsor

Neodent (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05649085

Collaborator

(none)

167

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Missing Teeth Prosthesis Survival	Device: Cobalt-Chromium (CoCr) prosthetic abutments

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

Anticipated Enrollment :

167 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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.