- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02703168
Long-term Performance of SLActive Implants After Immediate or Early Loading
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crestal bone level change by radiographic assessment
Time Frame: 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.
|
8 and 10 year post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant survival by clinical and radiographic assessment
Time Frame: 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).
|
8 and 10 year post-surgery
|
Incidence of adverse events and adverse device effects
Time Frame: 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.
|
8 and 10 year post-surgery
|
Collaborators and Investigators
Sponsor
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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR 03-05/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Partial Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Cairo UniversityNot yet recruiting
-
ZimVieCompleted
-
D'Albis DentalCompleted
-
Columbia UniversityCompleted
-
Addbio ABCompleted
-
Semmelweis UniversityInstitut Straumann AG; NSK Europe GmbH; Botiss Medical AG; Dicomlab Kft.; Hungarian... and other collaboratorsCompleted
-
Nobel BiocareTerminatedPartial EdentulismGermany
-
University of BelgradeCompleted