Partial Edentulism Clinical Trial
Official title:
Post-marketing Study to Document Long-term Performance of Straumann Tissue Level Implants With SLActive Surface in the Posterior Mandible and Maxilla After Immediate or Early Loading - Follow-up to Study CR 06/03
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed Written Informed Consent - Patients with Straumann SLActive tissue level implants, who participated in the Straumann CR06/03 clinical study. - Patients must be committed to the study for its full duration. - Patient's Radiographic stent must be available from study CR06/03 Exclusion Criteria: - Use of any investigational drug or device within 30 days before start of the study. - 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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institut Straumann AG |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
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