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

Sinus Floor Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02384291
• Other study ID #: ABT-BG-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2020

Study information

• Verified date: September 2018
• Source: Alpha - Bio Tec Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

Device:
• Alpha-Bio GRAFT Natural Bovine Bone
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
• natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alpha - Bio Tec Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]		6 months
Secondary	Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].		6 months

External Links

•   Sponsor site