N/A
N=136
Dental Implants With a SLActive® vs. SLA® Surface
Partially Edentulous Patients
Bottom Line
View on ClinicalTrials.gov: NCT03737357 ↗Enrolled (actual)
136
Serious AEs
2.9%
Results posted
Jun 2025
Primary outcome: Primary: Bone Level Change 12 Months After Implant Loading — 0.214; 0.056 mm — p=0.074
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SLActive® implant (Device); SLA® implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Level Change 12 Months After Implant Loading |
0.214; 0.056 | 0.074 |
| PRIMARY Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect |
14; 20; 0; 0 | — |
| SECONDARY Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations |
437.4; 508.3; 17.2; 8.6; 11.3; 8.4 | — |
| SECONDARY Change in Osseointegration Biomarkers Concentrations |
39.3; 26.0; 73.6; 28.6; 760.3; 2408.6 | — |
| SECONDARY Implant Survival |
3; 2 | — |
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.
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)
- 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.
Data sourced from ClinicalTrials.gov (NCT03737357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.