An observational study in Missing Teeth and Prosthesis Survival, sponsored by Neodent. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Neodent (part of Institut Straumann AG) · Observational
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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 167 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Neodent is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
First submitted after Neodent became part of Institut Straumann AG.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses
Prosthesis survival arte
Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.
Time frame: 24 months after provisional prosthesis installation
Implant survival rate
Survival rate of implant rehabilitated with prosthesis using CoCr abutments
Time frame: 24 months after provisional prosthesis installation
Implant success rate
Success rate of implant rehabilitated with prosthesis using CoCr abutments
Time frame: 24 months after provisional prosthesis installation
Patient satisfaction
Patient satisfaction with the treatment
Time frame: 24 months after provisional prosthesis installation
Clinician Satisfaction
Surgeon satisfaction after the installation of the prosthesis regarding the devices used
Time frame: 24 months after provisional prosthesis installation
Adverse events
• Occurrence of adverse events, device deficiencies and residual risks related to abutments, prostheses, and oral health.
Time frame: 24 months after provisional prosthesis installation
Risk factors
Influence of risk factors on observed results
Time frame: 24 months after provisional prosthesis installation
Plan to share: No
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