Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft

Study Overview
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Brief Summary
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This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation. Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis. Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.

Official Title
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Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial

Conditions
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Sinus Floor Augmentation

Intervention / Treatment
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* Device: Alpha-Bio GRAFT Natural Bovine Bone
* Device: natural bone substitute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study. Men and women over the age of 18 years. Patient has signed the Informed Consent. Exclusion Criteria: Chronic steroid therapy, Uncontrolled diabetes, Cardiovascular disease, Past irradiation of head and neck Maxillary sinus cysts, Active chronic sinusitis, Smoking more than ten cigarettes per day during the 3 months preceding this study . Malignant disease in the 5 years preceding this study Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia Disease that compromise the immune system Psychiatric disorder Hypersensitivity to titanium, collagen or bovine bone. Women who are pregnant or nursing. Patients with non-treated periodontal disease. Medical and/or general contraindications for intraoral surgical procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha-Bios GRAFT Natural Bovine Bone treatment<br>Pure Hydroxyapatite ceramic mineral with high similarity to the human bone | Device: Alpha-Bio GRAFT Natural Bovine Bone<br>* Pure Hydroxyapatite ceramic mineral with high similarity to the human bone<br>|
| Active Comparator: natural bone substitute<br>natural bone substitute material derived from the mineral portion of bovine bone | Device: natural bone substitute<br>* natural bone substitute material derived from the mineral portion of bovine bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites] |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation]. |  | 6 months |