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

• Status: Unknown status
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scil Technology GmbH
• Collaborator: FGK Clinical Research GmbH

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