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A prospective, observational, multicenter study where 60 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.
This will be a prospective, observational, multicenter study. All implants will be placed in the maxilla or mandible. The patient will either have a temporary prosthesis placed (out of occlusion) immediately (during the same implant placement visit or within 48 hours) or have a temporary or definitive prosthesis placed between 3-16 weeks following implant. Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery. All restorations will utilize the full range of the ZimVie prosthetic systems. The implant system will be evaluated yearly for 2 years.
Patients who are in need of treatment with dental implants in the maxilla and/or mandible. Those patients with tooth sites having prior failed implant(s) or in need of implant revisions, or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion.
A total of 60 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3 Pro dental implant system | Device | treatment of tooth loss with T3 Pro dental implants |
| Measure | Description | Time Frame |
|---|---|---|
| Integration success/ implant survival at 2 years; primary stability | the lack of implant mobility observed during 2 years duration; primary stability of the implant reached during implant placement as measured by placement torque and Resonance Frequency measures | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal bone regression | lack of bone loss observed and measured at 2 years | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Qualified patients (each patient having at least 1 tooth site treated) newly diagnosed with needing a dental implant (or more than one) in one or more tooth sites (edentulous or sick tooth in need of extraction) in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.
*Potential study participants please note: there are costs associated with the treatment(s) provided in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70119 | United States | ||
| University of Minnesota |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Minneapolis |
| Minnesota |
| 55455 |
| United States |