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

University Hospital of Cologne

Status: Unknown

Conditions: Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Treatments: Device: Bio-Oss xenograft; Device: Alpha-Bio's GRAFT Natural Bovine Bone

Study type: Interventional

Funder types: Other

Identifiers

NCT01781221

12-200

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Alpha-Bio's GRAFT Natural Bovine Bone

Active Comparator group

Description:

two different bone substitutes commonly used in dental procedures.

Treatment:

Device: Alpha-Bio's GRAFT Natural Bovine Bone

Bio-Oss xenograft

Active Comparator group

Description:

two different bone substitutes commonly used in dental procedures.

Treatment:

Device: Bio-Oss xenograft