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

NCT ID: NCT02703168

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Partial Edentulism

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Jackowski, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universität Witten/Herdecke

Tim Krafft, Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kieferchirurgische Praxisgemeinschaft, Weiden

Pedro Nicolau, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Coimbra

Other Identifiers

CR 03-05/11

Identifier Type: -

Identifier Source: org_study_id