Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
The purpose of the study is to gain experience of safety and efficacy with MD05 in man in
 alveolar bone regeneration.
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