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: 8.0 Level: LLT Classification code 10061257
Conditions
Interventions
Product Code: MD05
Pharmaceutical Form: Implant
INN or Proposed INN: Radotermin
CAS Number: 575458-75-2
Current Sponsor code: rhGDF-5
Other descriptive name: growth differentiation factor 5 (human),
Sponsors
Scil Technology GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Germany
Outcome results
None listed