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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02384291

Enrollment

Registered

2015-03-10

Start date

2014-05-31

Completion date

2020-06-30

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Augmentation

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.

Interventions

DEVICEAlpha-Bio GRAFT Natural Bovine Bone

Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

DEVICEnatural bone substitute

natural bone substitute material derived from the mineral portion of bovine bone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026