Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height
Conditions
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.
Interventions
DEVICEAlpha-Bio's GRAFT Natural Bovine Bone
DEVICEBio-Oss xenograft
Sponsors
University Hospital of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uneventful healing and histological bone formation | 6 months following sinus floor augmentation |
Secondary
| Measure | Time frame |
|---|---|
| X-ray demonstration of volume - stable results | 6 months following augmentation procedures. |
| Equally high implant survival rates and crestal bone loss | After 1,2 years |
Outcome results
None listed