Partially Edentulous Patients Clinical Trial
Official title:
A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01191073 -
Manually Versus Digitally Fabricated Removable Partial Dentures
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N/A |