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Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.

Healthy Clinical Trial

Official title:
A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation

Clinical Trial Summary

A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™ compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone to residual bone substitute.

Clinical Trial Description

This is a prospective, randomized, controlled study. The total study duration for each patient should be 9-14 months (from screening to last visit).

Enrolled subjects are randomized to one of the following groups:

1. Sinus floor elevation with Straumann® VivOss™

2. Sinus floor elevation with Geistlich Bio-Oss®

In total 6 visits per patient are scheduled in this study. The histological evaluation of the ratio of newly formed bone to residual bone graft, survival and success rate of study implants and adverse events (AEs) will be assessed.

The study devices Straumann® VivOss™ and Geistlich Bio-Oss are CE-(Conformité Européenne, meaning European Conformity) marked products.

Two centers, one in Germany and one in Switzerland will participate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02288182
Study type Interventional
Source Institut Straumann AG
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date February 2018
View Details
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