E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034536 |
E.1.2 | Term | Periodontal disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- Evidence of regeneration of alveolar bone evaluated by histomorphometry of block biopsies from the defect sites collected at 6 months postsurgery |
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E.2.2 | Secondary objectives of the trial |
- 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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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See protocol section 6.10 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |