Pilot Study on Safety and explorative Efficacy of MD05 in Comparison with the Medical Device Beta-TCP Mixed with Autogenous Bone Material in Patients Undergoing Two-Stage Unilateral Maxillary Sinus Floor Augmentation - Sinus Lift Study

• Conditions: Requirement of two-stage unilateral maxillary sinus floor augmentation in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants.; MedDRA version: 8.0Level: LLTClassification code 10061257

• Registration Number: EUCTR2005-003391-37-DE
• Lead Sponsor: Scil Technology GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-08
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
2. Residual bone height at the site of planned implantation > 1 mm and < 5 mm
3. Male and female outpatients, 18 to 75 years old
4. Female patients must be infertile (either sterilised or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.
5. Patient has given informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women of childbearing potential, lactating women
2. Participation in another clinical study within 30 days prior to study start
3. Previous participation in this study
4. Last dental extraction (maxilla, posterior to canine) within the last 3 months
5. Failed sinus lift surgery and previous eradictive maxillary sinus surgery (e.g. Caldwell-Luc surgery)
6. Simultaneously bilateral sinus lift
7. Legal incompetence or restricted legal competence
8. Alcoholism, drug dependency, smoking
9. Acute or chronic infection at the application site, e.g., sinusitis
10. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
11. Severe allergic rhinitis which requires permanent medication
12. Known intolerance of or hypersensitivity to beta-TCP or rhGDF-5
13. Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
14. Patients requiring chemo- or radiotherapy
15. Previous or current radiotherapy of the head
16. Chronic liver disorder (AST and/or ALT over 2 times upper limit of normal)
17. Impaired renal function (serum creatinine over 1.5 times upper limit of normal)
18. Uncontrolled, insulin-dependent diabetes mellitus (HbA1c > 7%)
19. Clinically relevant symptoms of thyroid dysfunction
20. Severe hypertension (RRdiast > 110 mmHg)
21. Clinically relevant cardiovascular disease, e.g., decompensated cardiac insufficiency, haemodynamically relevant heart valve defects, or myocardial infarction during the last three months
22. Systemic bone disease or illness having influence on bone metabolism, e.g. osteogenesis imperfecta, Paget's disease, Ehlers-Danlos disease, osteomalacia, renal osteodystrophia, hyperparathyroidism
23. Clinically relevant blood coagulation disorder, e.g., haemophilia, thrombocytopenia
24. Leukopenia < 3.500 leukocytes/µL
25. Previous (within last 2 months before screening visit) or current treatment with systemic corticosteroids of more than 5 mg/day prednisone equivalent (inhaled glucocorticoids are allowed)
26. Previous or current therapy with drugs having any influence on bone metabolism such as calcitonin or parathormone (as teriparatid) within the last 6 months before screening visit, bisphosphonates or fluoride at least for 30 days within the last 12 months before screening visit
27. Previous (within last 2 months before screening visit) or current treatment with immunosuppressant medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to determine the area of newly formed mineralised bone tissue (%) as assessed by histomorphometry 3 or 4 months after sinus floor augmentation (sinus lift) with either MD05 or the comparative product. ;Secondary Objective: Secondary objectives are the safety of MD05, bone quality, radiographic bone gain, area of remaining beta-TCP (%) and uneventful healing.;Primary end point(s): The primary efficacy parameter of interest is the proportion of the newly formed mineralised bone (%) as assessed by histomorphometry 3 or 4 months after sinus floor augmentation (sinus lift).