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

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital of Cologne
Sponsor:
Information provided by (Responsible Party):
University Hospital of Cologne
ClinicalTrials.gov Identifier:
NCT01781221
First received: January 10, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height
 Device: Alpha-Bio's GRAFT Natural Bovine Bone
Device: Bio-Oss xenograft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by University Hospital of Cologne:

Primary Outcome Measures:
  • Uneventful healing and histological bone formation [ Time Frame: 6 months following sinus floor augmentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • X-ray demonstration of volume - stable results [ Time Frame: 6 months following augmentation procedures. ] [ Designated as safety issue: No ]
  • Equally high implant survival rates and crestal bone loss [ Time Frame: After 1,2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: February 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT01781221     History of Changes
Other Study ID Numbers: 12-200
Study First Received: January 10, 2013
Last Updated: January 29, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on June 18, 2013