NCT02288182

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Straumann VivOss	Patients will receive Straumann VivOss for sinus augmentation.
DEVICE	Geistlich Bio-Oss	Patients will receive Geistlich Bio-Oss for sinus augmentation.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2018-02-01
• First posted: 2014-11-11
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

2 sites across 2 countries: Germany, Switzerland