Alveolar Ridge Augmentation
Conditions
Keywords
Sinus Lift Surgery, Sinus Floor Augmentation, Insufficient Bone Height
Brief summary
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
Interventions
DRUGMD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
DEVICEBeta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone
Sponsors
FGK Clinical Research GmbH
Scil Technology GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Residual bone height at the site of planned implantation \> 1 mm and \< 5 mm * Male and female outpatients, 18 to 75 years old * Female patients must be infertile (either sterilized 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. * Patient has given informed consent.
Exclusion criteria
* Women of childbearing potential, lactating women * Participation in another clinical study within 30 days prior to study start * Previous participation in this study * Last dental extraction (maxilla, posterior to canine) within the last 3 months * Failed sinus lift surgery and previous eradictive maxillary sinus surgery * Simultaneously bilateral sinus lift * Legal incompetence or restricted legal competence * Alcoholism, drug dependency, smoking * Acute or chronic infection at the application site, e.g., sinusitis * Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * Severe allergic rhinitis which requires permanent medication (Rosenlicht 1999) * Known intolerance of or hypersensitivity to beta-TCP or rhGDF-5 * Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years * Patients requiring chemo- or radiotherapy * Previous or current radiotherapy of the head * Chronic liver disorder * Impaired renal function * Uncontrolled, insulin-dependent diabetes mellitus * Clinically relevant symptoms of thyroid dysfunction * Severe hypertension (RRdiast \> 110 mmHg); * Clinically relevant cardiovascular disease * Systemic bone disease or illness having influence on bone metabolism, * Clinically relevant blood coagulation disorder, * Leukopenia \< 3.500 leukocytes/µL * Previous or current treatment with systemic corticosteroids * Previous or current therapy with drugs having any influence on bone metabolism * Previous or current treatment with immunosuppressant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. | Within 4 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| evidence of uncompromised healing | January 2008 |
Countries
Germany
Outcome results
None listed