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Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
The aim of the present study is to carry out post-marketing clinical monitoring of the medical device used in accordance with the instructions for use according to a medical strategy intended for the person who is suitable for this research which is not fixed in advance by an investigation plan and is part of the current practice of the surgeon.
This is a comparative, prospective, multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental prothesis | Device | 5 ranges of implants can be used : IDAll, IDBio, IDCam, IDMax, ID3 |
| Measure | Description | Time Frame |
|---|---|---|
| Osteointegration achieved between 2 and 6 months evaluated by clinical examination | Measurement of the stability index of the implant with OSSEO100 | between 2 and 6 months after the surgery (dental implantation) |
| Osteointegration achieved between 2 and 6 months evaluated by radiological examination | Measurement of the bone loss | between 2 and 6 months after the surgery (dental implantation) |
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Inclusion Criteria:
Subject receiving an insertion of an aesthetic and functional oral prosthesis on IDI implant systems (IDAll, IDBio, IDCam, IDMax or ID3) for at least one of the following indications:
Subject having received an information sheet on the study and having indicated their non-objection before starting the procedures specific to the protocol.
ASA score (American Society of Anesthesiologists) <3.
If a recent extraction has been performed at the site of the implantation area, the healing period should be at least 2 months.
Sufficient bone volume (minimum 4mm) to accommodate dental implants.
Exclusion Criteria:
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Adult population receiving an IDI implant under the conditions of use intended by the manufacturer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rony BOUKHRIS | Contact | 01.48.70.70.48 | rony.boukhris@idisystem.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Office | Recruiting | Paris | France |
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