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This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.
The main objectives of this study will be:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3 dental implant system | Device | This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental implant integration | The integration success measured by lack of mobility | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone Loss | The measured changes in peri-implant crestal bone levels | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas 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.
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| Name | Affiliation | Role |
|---|---|---|
| Hai Bo Wen, PhD | ZimVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Jersey Shore University Medical Center |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| Neptune City |
| New Jersey |
| 07753 |
| United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Dr. Daniel Engler-Hamm | München | 80333 | Germany |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |