E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Complication after tooth extraction - alveolar osteitis (dry socket). There is no causal treatment of alveolar osteitis. That’s why symptomatic therapy is used. Disinfectants are the most important agents for standard treatment of this disorder. Ozone is one of these substances. It is proved to be very efficient in wound healing in medicine. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013787 |
E.1.2 | Term | Dry socket |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013787 |
E.1.2 | Term | Dry socket |
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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 |
The main objective of this project is to evaluate a healing period of dry socket using ozone solution in water. |
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E.2.2 | Secondary objectives of the trial |
Other objectives are to decrease the recover period, to reduce subjective problems and to increase economic efficiency of therapy: decrease duration of disability reduction of drugs administration used in standard therapy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion ctiteria involve patients: - accountable men and women from 18 to 65 years old with diagnosed dry socket
- who are treated with diagnosis of dry socket at maxillofacial outpatient department, - who do not administer antimicrobial and antiinflammatory drugs because of other disorders |
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E.4 | Principal exclusion criteria |
Exclusion criteria involve patients: - under 18 years of age - pregnant and nursing women - who administer antimicrobial and antiinflammatory drugs because of other disorders - with diagnosed hyperthyreosis, diabetes mellitus and bleeding disorders - who receive antiagregant, anticoagulative and immunosupressive treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Allevation of subjective sympthoms of the patient (pain, oral malodour) and normalization of patient's objective status evaluated by an investigator (allevation of local and general signs of the disorder, e.g. swelling, erythema, oral malodour, reactive inflammation of lymphatic nodes, general health state) |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
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 | 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 | 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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The end of the trial is suspected after collection of 100 patients with diagnosed dry socket and completion of their treatment with ozonated water. |
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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 | |
E.8.9.1 | In the Member State concerned days | |