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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Subject must have voluntarily signed the informed consent before any study related action
Males and females with at least 18 years of age (including 18 years)
Subject needs augmentation procedure in the sinus to prepare for implant placement.
Subject must have a residual bone height of 2 to 4 mm.
Adequate oral hygiene ((Full mouth plaque index (O'Leary, et al. 1972 ) <25%) at baseline
Adequate control of inflammation ((full mouth bleeding on probing (Ainamo and Bay 1975)) ≤25% at baseline

Exclusion Criteria

Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
Any contraindications for general bone grafting and oral surgical procedures
Any anomalies of the sinus that could interfere with planned procedures
History of local irradiation therapy
Local inflammation, including untreated periodontitis
Medical conditions requiring chronic high dose steroid therapy
Treatment with an investigational drug or device within a 30 day period immediately prior to surgery at visit 2, or expected participation in any other investigational drug or device study during the conduct of this trial.
Antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
History of alcoholism or drug abuse
Immunocompromised subjects
Subjects who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
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
Physical or mental disabilities that would interfere with the ability to perform adequate oral hygiene
Current pregnancy (pregnancy test) and breastfeeding women

Secondary exclusion criterium:

Defects of the Schneider Membrane

Arm && Interventions

Group	Intervention	Description
Straumann VivOss	Straumann VivOss	Straumann® VivOss™Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of \> 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and \< 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
Geistlich Bio-Oss	Geistlich Bio-Oss	The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.

Primary Outcome Measures

Name	Time	Method
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®	6 months +/- 7 days after bone augmentation	Bone biopsies and histological staining

Secondary Outcome Measures

Name	Time	Method
Survival Rate of Study Implants (Based on Subjects)	4 months +/- 1 month after implant placement	Number of implants in place
Success Rate of Study Implants	4 months +/- 1 month after implant placement	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.

Locations (2): University of Zürich
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Zürich, Switzerland
Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
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Konstanz, Baden-Württemberg, Germany