Missing Teeth, Prosthesis Survival
Conditions
Keywords
dental implants, dental prosthesis
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.
Interventions
DEVICECobalt-Chromium (CoCr) prosthetic abutments
Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses
Sponsors
Neodent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis survival arte | 24 months after provisional prosthesis installation | Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Implant survival rate | 24 months after provisional prosthesis installation | Survival rate of implant rehabilitated with prosthesis using CoCr abutments |
| 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 |
| Clinician Satisfaction | 24 months after provisional prosthesis installation | Surgeon satisfaction after the installation of the prosthesis regarding the devices used |
Countries
Brazil
Contacts
Primary ContactAndrew Melenikiotis, MSc
Outcome results
None listed