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

Study Overview
=================
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: Sinus floor elevation with Straumann® VivOss™ 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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Straumann VivOss
* Device: Geistlich Bio-Oss


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Straumann VivOss<br>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. | Device: Straumann VivOss<br>* Patients will receive Straumann VivOss for sinus augmentation.<br>|
| Active Comparator: Geistlich Bio-Oss<br>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. | Device: Geistlich Bio-Oss<br>* Patients will receive Geistlich Bio-Oss for sinus augmentation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months +/- 7 days after bone augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate of Study Implants (Based on Subjects) | Number of implants in place | 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. | 4 months +/- 1 month after implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sinus augmentation procedure