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This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.
This is a prospective, randomized-controlled, multicenter study in which patients in need of dental implants in the posterior maxilla and mandible will be treated with either the T3 short implant (test device) or the T3 standard length implant (control device). Qualified patients will have one or more edentulous areas in the posterior region to be restored using a single crown. All implants will be placed using a single-stage surgical protocol. A provisional or definitive (final) prosthesis will be placed (cemented or screw-retained) within 8 weeks of implant placement. All prosthetic work must be completed no later than 6 months following implant placement surgery.
Each site will be selected to place implants (both test and control) in either the DCD or the non-DCD configuration (a total of 30 implants per site). Among all study sites, a total of 120 implants (60 test, 60 control) will be enrolled in this study (any geographic region). The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant. Only patients meeting the inclusion / exclusion criteria and providing informed consent form will be enrolled into study. The duration of the study will be approximately 4 years from initiation to completion of data analysis and reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3 short implant | Experimental | The short implants are available in lengths of 5mm and 6mm and in diameters of 5mm and 6mm. For study both configurations, T3 short without nano-scale Discrete Crystalline Deposition (non DCD- surface treatment) and T3 short with nano-scale Discrete Crystalline Deposition (with DCD- surface treatment), will be used. |
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| T3 standard length | Active Comparator | The T3 external hex implants available for this study will consist of lengths of 10mm, 11.5mm, 13mm, 15mm, 18mm and diameters of 4mm, 5mm, and 6mm. They have integrated platform switching (medialized implant/abutment junction). For study both configurations, T3 without nano-scale Discrete Crystalline Deposition (non DCD- surface treatment) and T3 with nano-scale Discrete Crystalline Deposition (with DCD- surface treatment), will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3 short and restoration (prosthesis) | Device | A qualified patient will be treated with a T3 short implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone regression | Assess and compare peri-implant crestal bone level changes between test and control device from baseline to 4 years | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant integration and survival | Assess and compare integration success (mobility and ISQ assessments) between test and control device from baseline to 4 years | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hai Bo Wen, PhD | ZimVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Xiaozhe Han | Boston | Massachusetts | 02111 | United States | ||
| Dr. Suheil Boutros |
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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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| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant.
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The randomization will be done using assignment from a computerized algorithm program. This will be done using a fixed block randomization scheme to ensure 1:1 ratio between test and control groups. Sealed envelopes containing randomization cards (code) will be used.
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| T3 standard length and restoration (prosthesis) | Device | A qualified patient will be treated with a T3 standard length implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years. |
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| Dearborn Heights |
| Michigan |
| 48127 |
| United States |
| Dr. Stefano Sivolella | Padova | 35127 | Italy |
| Dr. Jordi Gargallo | Tarragona | Catalonia | 43002 | Spain |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |