Long-term Performance of SLActive Implants After Immediate or Early Loading

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.

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Key information

Conditions

Partial Edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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).
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.

Sponsors and collaborators

Lead sponsor

Institut Straumann AG

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Mar 9, 2016
Registry last updated: Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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