Clinical trial NCT02703168: Long-term Performance of SLActive Implants After Immediate or Early Loading
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Edentulism
Keywords: Dental implants
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who participated in the Straumann clinical trial CR06/03

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Crestal bone level change by radiographic assessment
timeFrame: 8 and 10 year post-surgery
Secondary outcomes:
measure: Implant survival by clinical and radiographic assessment
timeFrame: 8 and 10 year post-surgery
measure: Incidence of adverse events and adverse device effects
timeFrame: 8 and 10 year post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Universität Witten/Herdecke
name: Joachim Jackowski, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kieferchirurgische Praxisgemeinschaft, Weiden
name: Tim Krafft, Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Coimbra
name: Pedro Nicolau, Dr.
role: PRINCIPAL_INVESTIGATOR
References: