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This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:
A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3 Certain Tapered implant with DCD | Experimental | Implant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. |
|
| T3 Certain Tapered implant without DCD | Active Comparator | Implant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3 Certain Tapered Implant | Device | Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading) |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival | Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant crestal bone levels | Assessed by radiographic measurements of serial crestal bone levels | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Jose | Providencia | Santiago Metropolitan | 1102 | Chile | ||
| Dr. George Papavasiliou |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2026 | May 21, 2026 | 6 | ||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
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| Athens |
| 15231 |
| Greece |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |