Dental Implants With a SLActive® vs. SLA® Surface

Partially Edentulous Patients Clinical Trial

Official title: A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Patients

• NCT number: NCT03737357
• Study type: Interventional
• Source: Institut Straumann AG
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2019
• Completion date: June 23, 2023