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| Name | Class |
|---|---|
| MIS Implant Technologies, Ltd | INDUSTRY |
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Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.
The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.
Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.
The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental implant (C1) | Active Comparator | Internal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption. Patient will be randomly assigned to one of the two groups after flap opening. |
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| Dental implant (V3) | Experimental | The unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement. Patient will be randomly assigned to one of the two groups after flap opening. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIS Implants | Device | The implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of implant survival and success rate of V3 and C1 implants | Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion. The hypothesis is those implant survival rates of the test (V3) and similar and that test V3 implant allows less peri-implant bone loss. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants | The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of aesthetic outcomes based on the pink esthetic score | The mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture will be assessed at baseline (crown placement) and at 1 year after the final restoration by using the Pink Esthetics Score (PES). | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| France LAMBERT | University of Liege | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège - Service de Médecine Dentaire | Liège | 4000 | Belgium |
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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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