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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Missing Teeth; Prosthesis Survival
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 167

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age who were previously subjected to the installation of GM dental implants by JJGC, at the ILAPEO College, between 2018 and 2022, who are using a healing abutment or cover screw, will receive treatment for installation of single-unit prostheses, screwed or cemented, in the maxilla or mandible, using CoCr abutments, in digital or conventional flow. Patients will be followed up and evaluated at different times over a 2-year period.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthesis survival arte	Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.	24 months after provisional prosthesis installation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neodent

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (ACTUAL): December 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: dental implants; dental prosthesis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Prosthesis Failure; Anodontia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium; Cobalt
• Other Study ID Numbers: CS.O.013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No