Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-13 @ 11:17 PM
Study NCT ID:
NCT02703168
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2015-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Performance of SLActive Implants After Immediate or Early Loading
Sponsor:
Institut Straumann AG
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: