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

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

Official Title
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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

Conditions
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Alveolar Bone Loss, Periodontal Bone Loss

Intervention / Treatment
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* Drug: MD05 and open flap debridement
* Procedure: Open flap debridement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Open flap debridement + MD05 | Drug: MD05 and open flap debridement<br>* recombinant human GDF-5 coated onto ß-tricalcium phosphate<br>|
| Active Comparator: 2<br>Open flap debridement | Procedure: Open flap debridement<br>* Open flap debridement alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of regeneration of alveolar bone. |  | October 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of uncompromised healing. |  | October 2008 |