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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Scil Technology GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by:
Scil Technology GmbH
ClinicalTrials.gov Identifier:
NCT00520377
First received: August 23, 2007
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Scil Technology GmbH:

Primary Outcome Measures:
  • Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. [ Time Frame: Within 4 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evidence of uncompromised healing [ Time Frame: January 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: January 2005
Estimated Study Completion Date: May 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MD05
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520377

Locations
Germany
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
Investigators
Principal Investigator: Wilfried Wagner, Prof Dr Dr Universitätsklinikum Mainz
  More Information

No publications provided

Responsible Party: Björn Capsius, Scil Technology GmbH
ClinicalTrials.gov Identifier: NCT00520377     History of Changes
Other Study ID Numbers: Scil-MD05-C01, Sinus Lift Study
Study First Received: August 23, 2007
Last Updated: April 22, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2014