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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001698-18 | EudraCT Number |
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The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octenidine Mouthwash | Experimental | 0.1% Octenidinedihydrochlorid Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days |
|
| Placebo | Placebo Comparator | Placebo Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octenidinedihydrochlorid | Drug | Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2 | The total mean PI is the sum of the individual scores divided by the number of investigated sites. | after 5 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial count reduction in saliva after a single administration of OML vs placebo | Bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration | after 1 minute of rinsing |
| Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with severe systemic diseases (e.g. hepatitis, human immunodeficiency virus [HIV] infection, tuberculosis, acute cancer treatment);
Subjects who require endocarditis prophylaxis for dental examination and treatment;
Subjects with caries requiring treatment (e.g. caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
Subjects who have a history of chronic or aggressive periodontitis;
Subjects with current moderate or severe chronic or aggressive periodontitis (periodontal screening index [PSI] >2 in more than 2 sextants or PSI >3);
Subjects showing a GI score of 3 on at least one tooth;
Subjects who underwent oral surgery within 14 days prior to Screening;
Subjects who used antiseptic mouth rinse within 14 days prior to Screening;
Subjects wearing orthodontic appliances and removable dentures (Wire-retainers after orthodontic treatment are allowed);
Subjects treated with antibiotics less than 3 months prior to the baseline examination at Visit 1 and/or planning such treatment for the duration of the study;
Subjects treated with systemically acting corticosteroids or corticosteroids applied via the oral cavity (e.g. asthma sprays);
Subjects who suffer from xerostomia;
Subjects who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure;
Participation of the subject in another clinical study within the last 4 weeks before enrolment in and during this study;
Incapability of assessing essence and possible consequences of the study (e.g. alcoholism);
Pregnant or breastfeeding women;
Women with childbearing potential except those who fulfill one of the following criteria:
Evidence suggesting that the subject is not likely to follow the study protocol (e.g. lacking compliance).
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Jockel-Schneider, Dr.med.dent. | Universitätsklinikum Würzburg, Poliklinik für Zahnerhaltung und Parodontologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätszahnklinik Wien, Fachbereich Zahnerhaltung und Parodontologie | Vienna | 1090 | Austria | |||
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| Placebo | Other | Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days |
|
The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4. |
| baseline and after 5 days of treatment |
| Incidence and severity of AEs (adverse events) | 5 days |
| Incidence of SAEs (serious adverse events) | 15 days |
| Change in tooth discoloration index from Visit 1 to Visit 2 | baseline and after 5 days of treatment |
| Poliklinik für Zahnerhaltung und Parodontologie des Universitätsklinikums Würzburg |
| Würzburg |
| Bavaria |
| 97070 |
| Germany |
| Poliklinik für Zahnerhaltung und Parodontologie der Universitätsklinik Köln | Cologne | North Rhine-Westphalia | 50931 | Germany |