E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Orthognathic surgery, cases of Bilateral Sagittal Split Osteotomy (B.S.S.O) of the mandible to achieve facial and occlusal balance. This could create bone gaps or continuity defects. These bone gaps can be small or quite large. Failure to graft these gaps can result in instability, relapse, and nonunion of the bone structures with subsequent redevelopment or worsening of the original deformity. |
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MedDRA Classification |
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 |
- Assessment of the efficacy of rshTF combined to a biosubsitute (Bio-Oss®, Geistlich) on mandible bone consolidation. - Assessment of the efficacy of rshTF combined to a collagen membrane (Bio-Gide®, Geistlich) on gingival cicatrisation.
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E.2.2 | Secondary objectives of the trial |
- Assessment of the safety of rshTF placed into the mandible. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with no hematological disorders, between 18 and 70 years old, requiring Bilateral Sagittal Split Osteotomy (BSSO) for repositioning of the mandible to achieve facial and occlusal balance and able to understand an informed consent. |
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E.4 | Principal exclusion criteria |
- All exclusion criteria that apply for general anesthesia - Bone graft failure within a year - Hematological disorder - Clinically relevant cardiovascular disorder - Severe hypertension - Diabetes mellitus - Acute or chronic infection at the application site - Severe allergic rhinitis requiring permanent medication - History or presence of local or systemic malignant disease - Patient requiring chemo- or radiotherapy of the head - Chronic liver disorder (aspartate aminotransferase and/or alaninaminotransferase over 2 times upper limit of normal) - Impaired renal function (creatinine over 1.5 times upper limit of normal) - Clinically relevant symptoms of thyroid dysfunction - Known infection of Human Immunodeficiency Virus , Hepatitis B Virus or Hepatitis C Virus - Aspirin or Aspirin derived history 2 weeks before intervention - NSAID intolerance - Pregnancy or lactation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy endpoints: - Quality of bone regeneration 6 and 24 weeks after surgery - Quality of gingival cicatrisation 6 and 24 weeks after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |