MedDRA version: 8.1 Level: LLT Classification code 10034536 Term: Periodontal disease
Conditions
Interventions
Product Code: MD05
Pharmaceutical Form: Implant
INN or Proposed INN: Radiotermin
CAS Number: 575458-75-2
Current Sponsor code: rhGDF-5
Other descriptive name: growth differentiation factor 5 (human),
Sponsors
Scil Technology GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evidence of regeneration of alveolar bone evaluated by histomorphometry of block biopsies from the defect sites collected at 6 months postsurgery;Secondary Objective: - Evidence of cementum regeneration evaluated by histomorphometry of block biopsies from the defect sites collected at 6 months postsurgery - Evidence of regeneration of the periodontal ligament evaluated by histomorphometry of block biopsies from the defect sites collected at 6 months postsurgery - Evidence of uncompromised healing with limited if any residual ß-TCP and associated tissue reactions evaluated by histomorphometry and histopathological observations - Evidence of uncompromised healing without aberrant healing reactions including root resorption and ankylosis evaluated by histomorphometry and histopathological observations - Evidence of clinical improvements evaluated by comparing the soft tissue profile at 6 months postsurgery to baseline (probing depth, clinical attachment level, gingival recession, gingival inflammation);Primary end point(s): The primary objective is evidence of regeneration of alveolar bone assessed by histomorphometry 6 months after treatment with MD05 or open-flap debridement. | — |
Countries
Hungary
Outcome results
None listed