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Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery

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:
NCT00519155
First received: August 21, 2007
Last updated: April 21, 2008
Last verified: April 2008

August 21, 2007
April 21, 2008
July 2007
October 2008   (final data collection date for primary outcome measure)
Evidence of regeneration of alveolar bone. [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
Evidence of regeneration of alveolar bone.
Complete list of historical versions of study NCT00519155 on ClinicalTrials.gov Archive Site
Evidence of uncompromised healing. [ Time Frame: October 2008 ] [ Designated as safety issue: Yes ]
Evidence of uncompromised healing.
Not Provided
Not Provided
 
Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
Pilot Study on Safety and Explorative Efficacy of MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery to Treat Deep Intrabony Defects

The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alveolar Bone Loss
  • Periodontal Bone Loss
  • Drug: MD05 and open flap debridement
    recombinant human GDF-5 coated onto ß-tricalcium phosphate
  • Procedure: Open flap debridement
    Open flap debridement alone
  • Experimental: 1
    Open flap debridement + MD05
    Intervention: Drug: MD05 and open flap debridement
  • Active Comparator: 2
    Open flap debridement
    Intervention: Procedure: Open flap debridement
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
20
November 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients requiring extraction of teeth with advanced intrabony periodontal defects at single rooted teeth without root concavities/furrows located in the maxilla and mandible (maxillary/mandibular premolars, maxillary incisors; presurgery probing depth ≥ 6 mm, intrasurgery defect depth ≥ 4 mm) or located the mesial or distal aspect of mandibular molar teeth without adjacent teeth (excluding defects also involving the furcation area).
  • Teeth to be treated must be scheduled for extraction in a treatment plan established by clinicians unrelated to the study.
  • Male and female patients, aged 18 - 75 years
  • Patients must be non-smokers
  • 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 must provide written informed consent

Exclusion Criteria:

  • Women of childbearing potential, pregnant or lactating women
  • Participation in another clinical study within 30 days prior to study start
  • Previous participation in this study
  • Legal incompetence or restricted legal competence
  • Alcoholism, drug dependency, smoking
  • Acute or chronic infection at the application site
  • Known infection with HIV, HBV, or HCV
  • Severe allergic rhinitis which requires permanent medication
  • Known intolerance of or hypersensitivity to ß-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 (AST and/or ALT over 2 times upper limit of normal)
  • Impaired renal function (creatinine over 1.5 times upper limit of normal)
  • Uncontrolled insulin-dependent diabetes mellitus (HbA1c > 7%)
  • Clinically relevant symptoms of thyroid dysfunction
  • Severe hypertension (RRdiast > 110 mmHg)
  • Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months
  • Systemic bone disease or illness having influence in bone metabolism (e.g. Osteogenesis imperfecta, Paget's disease, Ehlers-Danlos disease, osteomalacia, renal osteodystrophia, hyperparathyroidism)
  • Clinically relevant blood coagulation disorder
  • Leukopenia < 3.500 leukocytes/µL
  • Previous (within last 2 months before screening visit) or current treatment with systemic corticosteroids of more than 5 mg/day prednisone equivalent
  • Previous or current therapy with drugs having any influence on bone metabolism such as calcitonin or parathormone (as teriparatid) within the last 6 months before screening visit, bisphosphonates or fluoride at least for 30 days within the last 12 months before screening visit
  • Previous (within last 2 months before screening visit) or current treatment with immunosuppressant
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00519155
Scil-MD05-C02, EudraCT-No.: 2006-005883-25
No
Björn Capsius, Scil Technology GmbH
Scil Technology GmbH
FGK Clinical Research GmbH
Principal Investigator: Anton Sculean, Prof. Department of Periodontology; Radboud University Medical Center
Scil Technology GmbH
April 2008

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