Long-term Performance of SLActive Implants After Immediate or Early Loading
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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| 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 |
Outcome Measures
Primary Outcome Measures
- Crestal bone level change by radiographic assessment [8 and 10 year post-surgery]
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.
Secondary Outcome Measures
- Implant survival by clinical and radiographic assessment [8 and 10 year post-surgery]
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).
- Incidence of adverse events and adverse device effects [8 and 10 year post-surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed Written Informed Consent
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Patients with Straumann SLActive tissue level implants, who participated in the Straumann CR06/03 clinical study.
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Patients must be committed to the study for its full duration.
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Patient's Radiographic stent must be available from study CR06/03
Exclusion Criteria:
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Use of any investigational drug or device within 30 days before start of the study.
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Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Straumann AG
Investigators
- Principal Investigator: Joachim Jackowski, Prof., Universität Witten/Herdecke
- Principal Investigator: Tim Krafft, Dr. Dr., Kieferchirurgische Praxisgemeinschaft, Weiden
- Principal Investigator: Pedro Nicolau, Dr., University of Coimbra
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR 03-05/11