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

Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01781221
• Other study ID #: 12-200
• Status: Not yet recruiting
• Phase: N/A
• First received: January 10, 2013
• Last updated: January 29, 2013
• Start date: February 2013

Study information

• Verified date: January 2013
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Intervention

Device:
• Alpha-Bio's GRAFT Natural Bovine Bone

• Bio-Oss xenograft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uneventful healing and histological bone formation		6 months following sinus floor augmentation	No
Secondary	X-ray demonstration of volume - stable results		6 months following augmentation procedures.	No
Secondary	Equally high implant survival rates and crestal bone loss		After 1,2 years	No