Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
NCT ID: NCT00520377
Last Updated: 2008-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
31 participants
INTERVENTIONAL
2005-01-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
MD05
MD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
2
Beta-TCP and autologous bone
Beta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone
Interventions
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MD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
Beta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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FGK Clinical Research GmbH
INDUSTRY
Scil Technology GmbH
INDUSTRY
Responsible Party
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Scil Technology GmbH
Principal Investigators
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Wilfried Wagner, Prof Dr Dr
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Mainz
Locations
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Universitätsklinik Erlangen
Erlangen, Bavaria, Germany
Praxis Dr. Gath
München, Bavaria, Germany
IPI München GmbH
München, Bavaria, Germany
Praxis Dr. Schmidinger
Seefeld, Bavaria, Germany
Universitätsklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Klinikum der Universität Mainz
Mainz, Rheinland Pflaz, Germany
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Helios Klinik
Erfurt, Thuringia, Germany
Countries
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Other Identifiers
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Sinus Lift Study
Identifier Type: -
Identifier Source: secondary_id
Scil-MD05-C01
Identifier Type: -
Identifier Source: org_study_id