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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
Universidad Complutense
Madrid, Spain
Universidad de Santiago de Compostela
Santiago de Compostela, Spain
Bone Level Change 12 Months After Implant Loading
The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).
Time frame: 12 months after implant loading
Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect
Time frame: 12 months after implant loading
Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Change in inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.
Time frame: At implant placement, 1 and 4 weeks after implant placement
Change in Osseointegration Biomarkers Concentrations
Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.
Time frame: 1, 2, 4 and 8 weeks after implant placement
Implant Survival
Implant survival at 12 months after implant loading
Time frame: 12 months after implant loading
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