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

NCT02703168 | Completed

• 1 other identifier: CR 03-05/11
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Partial Edentulism

Keywords

Dental implants

Outcome Measures

Primary Outcomes (1)

• Crestal bone level change by radiographic assessment

  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 Outcomes (2)

• Implant survival by clinical and radiographic assessment

  8 and 10 year post-surgery

• Incidence of adverse events and adverse device effects

  8 and 10 year post-surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who participated in the Straumann clinical trial CR06/03

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Officials

• Joachim Jackowski, Prof.

  Universität Witten/Herdecke

  PRINCIPAL INVESTIGATOR

• Tim Krafft, Dr. Dr.

  Kieferchirurgische Praxisgemeinschaft, Weiden

  PRINCIPAL INVESTIGATOR

• Pedro Nicolau, Dr.

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: March 9, 2016
• Study Start: July 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share