A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Partially Edentulous Patients
- Sponsor
- Institut Straumann AG
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Bone Level Change 12 Months After Implant Loading
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •males and females, at least 18 years old
- •partially edentulous patients in need of two or more dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction)
- •subject must have voluntarily signed the informed consent, is willing and able to attend scheduled follow-up visits, and agrees that the encoded data will be collected and analyzed
Exclusion Criteria
- •any contraindications for oral surgical procedures
- •dental implant placement contraindicated according to Instructions for Use (IFU)
- •subjects with inadequate oral hygiene (FMPS ≥ 20%)
- •subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco
- •subjects with drug or alcohol abuse
- •patients requiring soft tissue and bone grafting procedures
- •inadequate bone volume
- •severe bruxism or clenching habits
- •women who are pregnant or planning to become pregnant at any point during the study duration.
- •patients who have systemic factors that could interfere with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses)
Outcomes
Primary Outcomes
Bone Level Change 12 Months After Implant Loading
Time Frame: 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).
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
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect
Secondary Outcomes
- Implant Survival(12 months after implant loading)
- Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations(At implant placement, 1 and 4 weeks after implant placement)
- Change in Osseointegration Biomarkers Concentrations(1, 2, 4 and 8 weeks after implant placement)