E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Number of remaining deep pockets after treatment of patients with chornic periodontitis |
Število preostalih globokih žepov po zdravljenju bolnikov s kroničnim parodontitisom |
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E.1.1.1 | Medical condition in easily understood language |
Number of remaining deep pockets after treatment of patients with chornic periodontitis |
Število preostalih globokih žepov o zdravljenju bolnikov s kroničnim parodontitisom |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060945 |
E.1.2 | Term | Bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone |
Ugotoviti, ali se število obolelih mest, ki ostanejo po dodatnem zdravljenju z antibiotikom azitromicinom razlikuje od števila obolelih mest po samostojnem odstranjevanju oblog z zobnih korenin |
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E.2.2 | Secondary objectives of the trial |
To determine if the treatment result is dependent on the presence of the most relevant periodontal pathogens (e. g. Aggregibacter actinomycetemcomitans) |
Ugotoviti, ali je učinek zdravljenja odvisen od priostnosti najpomembnejših parodontopatogenih bakterij, npr. Aggregibacter actinomycetemcomitans |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
This will include systemically healthy smokers and non-smokers aged between 25 and 65 years, with untreated, moderate to advanced form of chronic periodontitis ( Armitage 1999), which will have at least 16 teeth and at least 12 teeth suitable for the evaluation (not including wisdom teeth, teeth with orthodontic wires , bridges, crowns and implants ) having at least six sites with probing depth > 4 mm, clinical attachemnt loss ≥ 2 mm, and radiographic bone loss. |
Vključeni bodo sistemsko zdravi kadilci in nekadilci, stari med 25 in 65 let, z nezdravljeno, zmerno do napredovano obliko kroničnega parodontitisa (Armitage 1999), ki bodo imeli najmanj 16 zob in od tega najmanj 12 zob primernih za ovrednotenje (ne vključuje modrostnih zob, zob z ortodontskimi žicami, mostički, prevlekami in implantatov). Na vsaj 6 mestih bo globina sondiranja > 4 mm, klinična izguba prirastišča ≥ 2 mm in rentgensko vidna izguba kosti. |
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E.4 | Principal exclusion criteria |
Excluded will be systemically ill (diabetes, cancer patients, HIV infection, and patients with metabolic bone diseases and diseases that disrupt the processes of wound healing, patients treated with radiation or chemotherapy , immunosuppressants, anti-epileptic drugs, calcium channel blockers, non-steroidal anti-inflammatory drugs, pregnant women and breastfeeding women and patients who have been in the last 12 months treated with antibiotics, allergic or with suspected hypersensitivity to azithromycin , patients who have been in the last year treated due to periodontal disease.
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Izključeni bodo sistemsko bolni (sladkorni bolniki, rakavi bolniki, okuženi z virusom HIV, bolniki z metabolnimi kostnimi boleznimi ter boleznimi, ki motijo procese celjenja ran, bolniki zdravljeni z obsevanjem ali kemoterapijo, imunosupresivi, antiepileptičnimi zdravili, kalcijevimi antagonisti, nesteroidnimi antirevmatičnimi zdravili, nosečnice in doječe matere, pacienti, ki so jih v zadnjih 12 mesecih zdravili z antibiotiki, preobčutljivi ali s sumom na preobčutljivost na azitromicin, pacienti, ki so jih v zadnjem letu zaradi parodontalne bolezni zdravili z luščenjem in glajenjem korenin ali kirurško |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone |
Ugotoviti, ali se število obolelih mest, ki ostanejo po dodatnem zdravljenju z antibiotikom azitromicinom razlikuje od števila obolelih mest po samostojnem odstranjevanju oblog z zobnih korenin |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3, 6 and 12 months |
3, 6 in 12 mesecev |
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E.5.2 | Secondary end point(s) |
To determine if the treatment result is dependent on the presence of the most relevant pariodontal pathogens (e. g. Aggregibacter actinomycetemcomitans) |
Ugotoviti, ali je učinek zdravljenja odvisen od priostnosti najpomembnejših parodontopatogenih bakterij, npr. Aggregibacter actinomycetemcomitans |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |