Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft
NCT ID: NCT02384291
Last Updated: 2019-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2014-05-31
2020-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alpha-Bios GRAFT Natural Bovine Bone 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
natural bone substitute
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Men and women over the age of 18 years.
3. Patient has signed the Informed Consent.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Alpha - Bio Tec Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Rothamel, Priv-Doz Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne
Related Links
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Sponsor site
Other Identifiers
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ABT-BG-01
Identifier Type: -
Identifier Source: org_study_id
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