Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
This trial is active, not recruiting.
|Conditions||alveolar bone loss, periodontal bone loss|
|Treatments||md05 and open flap debridement, open flap debridement|
|Sponsor||Scil Technology GmbH|
|Collaborator||FGK Clinical Research GmbH|
|Start date||July 2007|
|End date||October 2008|
|Trial size||20 participants|
|Trial identifier||NCT00519155, EudraCT-No.: 2006-005883-25, Scil-MD05-C02|
The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Open flap debridement + MD05
Open flap debridement
Evidence of regeneration of alveolar bone.
time frame: October 2008
Evidence of uncompromised healing.
time frame: October 2008
Male or female participants from 18 years up to 75 years old.
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
|Official title||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|
|Principal investigator||Anton Sculean, Prof.|
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