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

Straumann

Status: Completed

Conditions: Partial Edentulism

Study type: Observational

Funder types: Industry

Identifiers

NCT02703168

CR 03-05/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

66 participants in 2 patient groups

Immediate loading

Description:

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

Description:

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