Dental Implants With a SLActive® vs. SLA® Surface

Not Applicable

Completed

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.

Recruitment & Eligibility

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)
patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa)
conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Primary Outcome Measures

Name	Time	Method
Bone Level Change 12 Months After Implant Loading	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	12 months after implant loading	Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect

Secondary Outcome Measures

Name	Time	Method
Implant Survival	12 months after implant loading	Implant survival at 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 inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.
Change in Osseointegration Biomarkers Concentrations	1, 2, 4 and 8 weeks after implant placement	Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.

Locations (2): Universidad Complutense
🇪🇸
Madrid, Spain
Universidad de Santiago de Compostela
🇪🇸
Santiago De Compostela, Spain
Universidad Complutense
🇪🇸Madrid, Spain