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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients will receive Straumann VivOss for sinus augmentation.
Patients will receive Geistlich Bio-Oss for sinus augmentation.
Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
Konstanz, Baden-Wurttemberg, Germany
University of Zürich
Zurich, Switzerland
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
Bone biopsies and histological staining
Time frame: 6 months +/- 7 days after bone augmentation
Survival Rate of Study Implants (Based on Subjects)
Number of implants in place
Time frame: 4 months +/- 1 month after implant placement
Success Rate of Study Implants
Buser success criteria: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency.
Time frame: 4 months +/- 1 month after implant placement
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