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

August 23, 2007
April 22, 2008
January 2005
December 2007   (final data collection date for primary outcome measure)
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. [ Time Frame: Within 4 months after surgery ] [ Designated as safety issue: No ]
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. [ Time Frame: Within 4 months after surgery ]
Complete list of historical versions of study NCT00520377 on ClinicalTrials.gov Archive Site
evidence of uncompromised healing [ Time Frame: January 2008 ] [ Designated as safety issue: Yes ]
Evidence of uncompromised healing [ Time Frame: Within 9 months after surgery ]
Not Provided
Not Provided
 
Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alveolar Ridge Augmentation
  • Drug: MD05
    recombinant human GDF-5 coated onto beta-tricalcium phosphate
  • Device: Beta-TCP and autologous bone
    beta-tricalcium phosphate and autologous bone
  • Experimental: 1
    MD05
    Intervention: Drug: MD05
  • Active Comparator: 2
    Beta-TCP and autologous bone
    Intervention: Device: Beta-TCP and autologous bone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
May 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00520377
Scil-MD05-C01, Sinus Lift Study
No
Björn Capsius, Scil Technology GmbH
Scil Technology GmbH
FGK Clinical Research GmbH
Principal Investigator: Wilfried Wagner, Prof Dr Dr Universitätsklinikum Mainz
Scil Technology GmbH
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP