Clinical trial NCT03737357: Dental Implants With a SLActive® vs. SLA® Surface
Official title: A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Patients
Keywords: dental implants
SLActive® surface
biomarkers
BLT implant
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bone Level Change 12 Months After Implant Loading
timeFrame: 12 months after implant loading
measure: Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
timeFrame: 12 months after implant loading
Secondary outcomes:
measure: Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
timeFrame: At implant placement, 1 and 4 weeks after implant placement
measure: Change in Osseointegration Biomarkers Concentrations
timeFrame: 1, 2, 4 and 8 weeks after implant placement
measure: Implant Survival
timeFrame: 12 months after implant loading
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense
city: Santiago De Compostela
country: Spain
facility: Universidad de Santiago de Compostela
Study officials:
affiliation: Professor and Chairman of Periodontology
name: Mariano Sanz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor in Periodontology
name: Juan Blanco-Carrión, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: