Dental Implants With a SLActive® vs. SLA® Surface

Not Applicable

Active, not recruiting

• Conditions: Partially Edentulous Patients
• Interventions: Device: SLActive® implant; Device: SLA® implant

• Registration Number: NCT03737357
• Lead Sponsor: Institut Straumann AG

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.

Study Timeline

• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2019-10-09
• Status Verified: 2022-10
• Primary Completion: 2023-03-09
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Study Completion: 2023-06-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLActive® implant	SLActive® implant	-
SLA® implant	SLA® implant	-

Primary Outcome Measures

Name	Time	Method
Bone Level Change	12 months after implant loading	Bone level change at 12 months after implant loading
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
Change in inflammatory and anti-inflammatory biomarkers concentrations	30 days 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	between day 7 and 8 weeks after implant placement	Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.
Bone Level Change	between implant placement and loading and between loading and 12 months after implant loading	Bone Level Change between implant placement and loading and between loading and 12 months after implant loading
Implant survival	12 months after implant loading	Implant survival at 12 months after implant loading

Trial Locations

Locations (2)

Universidad de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Universidad Complutense; 🇪🇸 Madrid, Spain