Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Alpha - Bio Tec Ltd.
- Enrollment
- 44
- Primary Endpoint
- Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alpha-Bios GRAFT Natural Bovine Bone treatment
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
Intervention: Alpha-Bio GRAFT Natural Bovine Bone (Device)
natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone
Intervention: natural bone substitute (Device)
Outcomes
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].(6 months)