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

Partial Edentulism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703168
• Other study ID #: CR 03-05/11
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: March 3, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionPortugal: Health Ethic Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Partial Edentulism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implant survival by clinical and radiographic assessment	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).	8 and 10 year post-surgery	No
Secondary	Incidence of adverse events and adverse device effects	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.	8 and 10 year post-surgery	Yes