Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 5:50 AM
Study NCT ID:
NCT03737357
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dental Implants With a SLActive® vs. SLA® Surface
Sponsor:
Institut Straumann AG
Organization:
Study Overview
Official Title:
A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface
Status:
COMPLETED
Status Verified Date:
2025-02
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 post-market study is to show that dental implants with a SLActive® surface (SLActive® implants) show non-inferior clinical performance compared to dental implants with a SLA® surface (SLA® implants). The primary hypothesis is that 12 months after implant loading, the bone loss around the SLActive® implants will not be appreciably greater than around the SLA® implants.
The occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the Straumann® Bone Level Tapered (BLT), Roxolid® implant.
Osseointegration and anti-inflammatory potential of SLActive® implants will be evaluated in the study as secondary endpoints.
The occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the Straumann® Bone Level Tapered (BLT), Roxolid® implant.
Osseointegration and anti-inflammatory potential of SLActive® implants will be evaluated in the study as secondary endpoints.
Detailed Description:
This is a prospective, single-blinded, randomized, paired sample, multi-center clinical study. Eight visits per patient are scheduled in this study. The final analysis will be conducted after all patients completed the 12-month visit.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
Two centers in Spain will participate.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
Two centers in Spain will participate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: