pilot study on md05 in comparison with open flap debridement in patients undergoing periodontal surgery

Conditions: Alveolar Bone Loss; Periodontal Bone Loss

Summary: the purpose of the study is to gain experience of safety and efficacy with md05 in man in alveolar bone regeneration.


Eligibility criteria:
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