E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic paradontitis in adults with at least 16 own teeth |
Chronische Parodontitis bei Erwachsenen mit mindestens 16 eigenen Zähnen |
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E.1.1.1 | Medical condition in easily understood language |
Chronic bacterial inflammation of the gingiva |
Chronische bakterielle Entzündung des Zahnfleisches |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
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 |
Comparison of variation in bleeding propensity of the gingiva between both treatment groups |
Vergleich der Veränderung der klinischen Blutungsneigung der Gingiva zwischen den Behandlungsgruppen |
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E.2.2 | Secondary objectives of the trial |
Comparison of variation in probing depth and loss of attachment between both treatment groups |
Vergleich der Veränderung der klinischen Sondierungstiefe und des Attachmentverlustes zwischen beiden Behandlungsgruppen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Indication: chronic parodontis (PSI 3 and 4) Age: 25 to 85 years Minimum of gingival bleeding at six different sites Minimum of 16 own teeth without relevant supernatant crowns or restauration edges
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Indikation: chronische Parodontitis (PSI 3 und 4) Alter: 25 - 85 Jahren Blutung ist an mindestens sechs Stellen feststellbar Mindestens 16 eigene Zähne ohne relevant überstehende Kronen- oder Restaurationsränder
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E.4 | Principal exclusion criteria |
Patients requiring acute parodontal or endodontological treatment Patients with heart-, kidney, liver diseases, as well as know diabetics and tumor patients, especially patients treated with anticoagulants Patients with injuries in the mouth cavity Known hypersensitivity against one of the applied IMP or their ingredients or medications with similar chemical structure Patients being treated with antibiotics, anticoagulants or antiphlogistic medication 14 days prior to being enrolled in the study Pregnancy and breast feeding Smoking |
Patienten mit akutem parodontalen oder endodontologischen Behandlungsbedarf Patienten mit Herz-, Nieren- oder Lebererkrankungen sowie bekannte Diabetiker und Tumorpatienten, insbesondere Patienten, die Gerinnungshemmer einnehmen Patienten mit Verletzungen im Mundraum Anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur Patienten, welche bis 14 Tage vor Versuchsbeginn mit Antibiotika, Antikoagulantien oder entzündungshemmenden Mitteln behandelt wurden. Teilnahme an einer anderen klinischen Studie innerhalb der letzten drei Monate vor dem Einschluss Patienten, mit einem Gesundheitszustand, der Einfluss auf die Durchführung der klinischen Studie hat (z.B. erhöhtes Bakteriämierisiko und immunsupprimierte Patienten) Schwangere und Stillende Raucher
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E.5 End points |
E.5.1 | Primary end point(s) |
Bleeding upon probing and the number of bleeding sites |
Blutung nach Sondierung und die Anzahl blutender Stellen |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 20 (+3 days if necessary) of treatment |
Tag 20 (+ 3 Tage falls erforderlich) der Behandlung |
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E.5.2 | Secondary end point(s) |
Probing depth and loss of attachment |
Sondierungstiefe und Attachmentverlust |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 21 (+3 days if necessary) of treatment |
Tag 21 (+ 3 Tage falls erforderlich) der Behandlung |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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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LVLS |
Letzte Visite des letzten Patienten |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |