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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobalt-Chromium (CoCr) prosthetic abutments | Device | Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Melenikiotis, MSc | Contact | +55 41 3595-6000 | amelenikiotis@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Waleska Caldas | Neodent | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO) | Recruiting | Curitiba | Brazil |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| 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 |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |