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

July 14, 2019 updated by: Alpha - Bio Tec Ltd.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpha - Bio Tec Ltd.

Investigators

  • Principal Investigator: Daniel Rothamel, Priv-Doz Dr., Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 14, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ABT-BG-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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