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

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ClinicalTrials.gov Identifier: NCT02384291
Recruitment Status : Active, not recruiting
First Posted : March 10, 2015
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alpha - Bio Tec Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sinus Floor Augmentation Device: Alpha-Bio GRAFT Natural Bovine Bone Device: natural bone substitute Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
Study Start Date : May 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arms and Interventions
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Arm Intervention/treatment
Experimental: Alpha-Bios GRAFT Natural Bovine Bone treatment
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
 Device: Alpha-Bio GRAFT Natural Bovine Bone
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
Active Comparator: natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone
 Device: natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone


Outcome Measures
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Primary Outcome Measures :
  1. Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites] [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation]. [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384291


Sponsors and Collaborators
Alpha - Bio Tec Ltd.
Investigators
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Principal Investigator: Daniel Rothamel, Priv-Doz Dr. Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne
More Information
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Additional Information:
Sponsor site  This link exits the ClinicalTrials.gov site

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Responsible Party: Alpha - Bio Tec Ltd.
ClinicalTrials.gov Identifier: NCT02384291     History of Changes
Other Study ID Numbers: ABT-BG-01
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: September 2018