This trial is active, not recruiting.

Condition sinus floor augmentation
Treatments alpha-bio graft natural bovine bone, natural bone substitute
Phase phase 4
Sponsor Alpha - Bio Tec Ltd.
Start date May 2014
End date December 2016
Trial size 44 participants
Trial identifier NCT02384291, ABT-BG-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
alpha-bio graft natural bovine bone
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
(Active Comparator)
natural bone substitute material derived from the mineral portion of bovine bone
natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone

Primary Outcomes

Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
time frame: 6 months

Secondary Outcomes

Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Men and women over the age of 18 years. 3. Patient has signed the Informed Consent. Exclusion Criteria: 1. Chronic steroid therapy, 2. Uncontrolled diabetes, 3. Cardiovascular disease, 4. Past irradiation of head and neck 5. Maxillary sinus cysts, 6. Active chronic sinusitis, 7. Smoking more than ten cigarettes per day during the 3 months preceding this study . 8. Malignant disease in the 5 years preceding this study 9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia 10. Disease that compromise the immune system 11. Psychiatric disorder 12. Hypersensitivity to titanium, collagen or bovine bone. 13. Women who are pregnant or nursing. 14. Patients with non-treated periodontal disease. 15. Medical and/or general contraindications for intraoral surgical procedures

Additional Information

Official title Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
Principal investigator Daniel Rothamel, Priv-Doz Dr.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Alpha - Bio Tec Ltd..