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

Not Applicable

• Conditions: Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height
• Interventions: Device: Bio-Oss xenograft; Device: Alpha-Bio's GRAFT Natural Bovine Bone

• Registration Number: NCT01781221
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-29
• Last Update Submitted: 2013-01-29
• Study First Posted: 2013-01-31
• Last Update Posted: 2013-01-31
• Study Start: 2013-02
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-Oss xenograft	Bio-Oss xenograft	two different bone substitutes commonly used in dental procedures.
Alpha-Bio's GRAFT Natural Bovine Bone	Alpha-Bio's GRAFT Natural Bovine Bone	two different bone substitutes commonly used in dental procedures.

Primary Outcome Measures

Name	Time	Method
Uneventful healing and histological bone formation	6 months following sinus floor augmentation

Secondary Outcome Measures

Name	Time	Method
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