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This is a follow-up study with patients, who participated in the Straumann clinical study CR06/03. The objective is the assessment of long-term data (8 and 10 years after implantation) on the performance of immediate and early (28-34 days post implantation) non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and mandible.
The primary objective is of the study is to analyse the change in crestal bone levels 8 and 10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the immediate and early loading group.
This is a prospective, post-market, open label, follow-up multicenter study with patients who participated in the Straumann clinical study CR06/03. The total study duration for each patient should be 2 years.
In total 2 visits are scheduled in this study. Bone level changes, implant success and survival, performance of the restorative components, and adverse events (AEs) will be assessed.
The study device is a CE-marked product and FDA approved.
Three centres, one in Portugal and two in Germany, will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate loading | Patients were allocated to treatment group in the core study. Immediate loading was defined as follows: Implant(s) will be restored with a temporary restoration on the day of surgery | ||
| Early loading | Patients were allocated to treatment group in the core study. Early loading was defined as follows: Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Crestal bone level change by radiographic assessment | To evaluate the changes in crestal bone levels (in millimetre) in relation to defined implant reference point and different time points (between baseline at implant insertion and follow-up time points at 8 and 10 years after implant insertion) in the maxilla and mandible of the immediate and early loading groups. | 8 and 10 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival by clinical and radiographic assessment | To evaluate the implant survival rate by clinically and radiographically count of implants still in place in the subject's jaw bone at the time of assessment (8 and 10 years post-surgery). The implant survival rates will be compared between the treatment groups (immediate loading and early loading). | 8 and 10 year post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who participated in the Straumann clinical trial CR06/03
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Jackowski, Prof. | Universität Witten/Herdecke | Principal Investigator |
| Tim Krafft, Dr. Dr. | Kieferchirurgische Praxisgemeinschaft, Weiden | Principal Investigator |
| Pedro Nicolau, Dr. | University of Coimbra | Principal Investigator |
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| Incidence of adverse events and adverse device effects | Total number of AEs and total number of AEs related to the study treatment (device-related or procedure-related), as well as the total number of subjects affected by at least one adverse event wil be calculated per treatment group. | 8 and 10 year post-surgery |