Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781221
Recruitment Status : Unknown
Verified January 2013 by University Hospital of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
University Hospital of Cologne

Brief Summary:
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.

Condition or disease Intervention/treatment Phase
Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height Device: Alpha-Bio's GRAFT Natural Bovine Bone Device: Bio-Oss xenograft Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : January 2018

Arm Intervention/treatment
Active Comparator: Alpha-Bio's GRAFT Natural Bovine Bone
two different bone substitutes commonly used in dental procedures.
Device: Alpha-Bio's GRAFT Natural Bovine Bone
Active Comparator: Bio-Oss xenograft
two different bone substitutes commonly used in dental procedures.
Device: Bio-Oss xenograft

Primary Outcome Measures :
  1. Uneventful healing and histological bone formation [ Time Frame: 6 months following sinus floor augmentation ]

Secondary Outcome Measures :
  1. X-ray demonstration of volume - stable results [ Time Frame: 6 months following augmentation procedures. ]
  2. Equally high implant survival rates and crestal bone loss [ Time Frame: After 1,2 years ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
  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.

Responsible Party: University Hospital of Cologne Identifier: NCT01781221     History of Changes
Other Study ID Numbers: 12-200
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013