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 - Scil-MD05-C02
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10034536Term: Periodontal disease
- Registration Number
- EUCTR2006-005883-25-HU
- Lead Sponsor
- Scil Technology GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.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).
2.Teeth which to be included in the study must be scheduled for extraction in the overall treatment plan offered to the patient by clinicians unrelated to the study.
3.Male and female patients, aged 18 – 75 years
4.Patients must be non-smokers
5.Female patients must be infertile (either sterilized or post-menopausal). 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.
6.Patient must provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Women of childbearing potential, pregnant or lactating women
2.Participation in another clinical study within 30 days prior to study start
3.Previous participation in this study
4.Legal incompetence or restricted legal competence
5.Alcoholism, drug dependency, smoking
6.Acute or chronic infection at the application site
7.Known infection with HIV, HBV, or HCV
8.Severe allergic rhinitis which requires permanent medication
9.Known intolerance of or hypersensitivity to ß-TCP or rhGDF 5
10.Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
11.Patients requiring chemo- or radiotherapy
12.Previous or current radiotherapy of the head
13.Chronic liver disorder (AST and/or ALT over 2 times upper limit of normal)
14.Impaired renal function (creatinine over 1.5 times upper limit of normal)
15.Uncontrolled insulin-dependent diabetes mellitus (HbA1c > 7%)
16.Clinically relevant symptoms of thyroid dysfunction
17.Severe hypertension (RRdiast > 110 mmHg)
18.Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, haemodynamically relevant heart valve defects, or myocardial infarction during the last 3 months
19.Systemic bone disease or illness having influence in bone metabolism (e.g. Osteogenesis imperfecta, Paget’s disease, Ehlers-Danlos disease, osteomalacia, renal osteodystrophia, hyperparathyroidism)
20.Clinically relevant blood coagulation disorder
21.Leukopenia < 3.500 leukocytes/µL
22.Previous (within last 2 months before screening visit) or current treatment with systemic corticosteroids of more than 5 mg/day prednisone equivalent
23.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
24.Previous (within last 2 months before screening visit) or current treatment with immunosuppressant medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method