Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

Study Overview
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Brief Summary
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The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.

Official Title
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Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

Conditions
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Alveolar Ridge Augmentation

Intervention / Treatment
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* Drug: MD05
* Device: Beta-TCP and autologous bone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MD05 | Drug: MD05<br>* recombinant human GDF-5 coated onto beta-tricalcium phosphate<br>|
| Active Comparator: 2<br>Beta-TCP and autologous bone | Device: Beta-TCP and autologous bone<br>* beta-tricalcium phosphate and autologous bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. |  | Within 4 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of uncompromised healing |  | January 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus Lift Surgery, Sinus Floor Augmentation, Insufficient Bone Height