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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Missing Teeth, Prosthesis Survival

Intervention / Treatment
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* Device: Cobalt-Chromium (CoCr) prosthetic abutments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cobalt-Chromium (CoCr) prosthetic abutments|Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, dental prosthesis