Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial
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ClinicalTrials.gov 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
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Sponsor:
University Hospital of Cologne
Information provided by (Responsible Party):
University Hospital of Cologne
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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.
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Device: Alpha-Bio's GRAFT Natural Bovine Bone |
Active Comparator: Bio-Oss xenograft
two different bone substitutes commonly used in dental procedures.
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Device: Bio-Oss xenograft |
Primary Outcome Measures
:
- Uneventful healing and histological bone formation [ Time Frame: 6 months following sinus floor augmentation ]
Secondary Outcome Measures
:
- X-ray demonstration of volume - stable results [ Time Frame: 6 months following augmentation procedures. ]
- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
- Men and women over the age of 18 years.
- Patient has signed the Informed Consent.
Exclusion Criteria:
- Chronic steroid therapy.
- Uncontrolled diabetes.
- Cardiovascular disease.
- Past irradiation of head and neck.
- Maxillary sinus cysts.
- Active chronic sinusitis.
- Smoking more than ten cigarettes per day during the 3 months preceding this study .
- Malignant disease in the 5 years preceding this study.
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Disease that compromise the immune system
- Psychiatric disorder
- Hypersensitivity to titanium, collagen or bovine bone.
- Women who are pregnant or nursing.
- Patients with non-treated periodontal disease.
- Medical and/or general contraindications for intraoral surgical procedures.
No Contacts or Locations Provided
Responsible Party: | University Hospital of Cologne |
ClinicalTrials.gov 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 |