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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520377
Recruitment Status : Unknown
Verified April 2008 by Scil Technology GmbH.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2007
Last Update Posted : April 23, 2008
FGK Clinical Research GmbH
Information provided by:
Scil Technology GmbH

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

Condition or disease Intervention/treatment Phase
Alveolar Ridge Augmentation Drug: MD05 Device: Beta-TCP and autologous bone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: 1
Drug: MD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
Active Comparator: 2
Beta-TCP and autologous bone
Device: Beta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone

Primary Outcome Measures :
  1. Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. [ Time Frame: Within 4 months after surgery ]

Secondary Outcome Measures :
  1. evidence of uncompromised healing [ Time Frame: January 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520377

Universitätsklinik Erlangen
Erlangen, Bayern, Germany, 91054
Praxis Dr. Gath
München, Bayern, Germany, 80336
IPI München GmbH
München, Bayern, Germany, 81925
Praxis Dr. Schmidinger
Seefeld, Bayern, Germany, 82229
Universitätsklinik Düsseldorf
Düsseldorf, Nordrhein Westfalen, Germany, 40225
Klinikum der Universität Mainz
Mainz, Rheinland Pflaz, Germany, 55131
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig Holstein, Germany, 24105
Helios Klinik
Erfurt, Thüringen, Germany, 99089
Charité Universitätsmedizin Berlin
Berlin, Germany, 12203
Sponsors and Collaborators
Scil Technology GmbH
FGK Clinical Research GmbH
Principal Investigator: Wilfried Wagner, Prof Dr Dr Universitätsklinikum Mainz

Responsible Party: Björn Capsius, Scil Technology GmbH Identifier: NCT00520377     History of Changes
Other Study ID Numbers: Scil-MD05-C01
Sinus Lift Study
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by Scil Technology GmbH:
Sinus Lift Surgery
Sinus Floor Augmentation
Insufficient Bone Height