Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT 0.1% vs. Placebo | Active Comparator | 0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
|
| OCT 0.15% vs. Placebo | Active Comparator | 0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
|
| OCT 2.0% vs. Placebo | Active Comparator | 0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octenidine dihydrochloride | Drug | Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial count reduction in saliva after a single application of OML in comparison to placebo application | Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design | After 1 minute of rinsing |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plaque index (PI) | PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design | After 5 days of application |
| Change in mean gingival index (GI) | GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
Patients who require endocarditis prophylaxis for dental examination and treatment
Caries requiring treatment (e.g. caries with cavity) or other oral diseases (incl. gingival hyperplasia, diseases of the oral mucosa, periodontal screening index PSI > 2)
Patients with orthodontic appliances and removable dentures
Patients treated with antibiotics less than 3 months prior to the baseline examination at V1 and/or such a treatment planned for the duration of the trial
Patients chronically treated with steroids
Patients who suffer from xerostomia
Patients who regularly smoke more than 10 cigarettes per day
Patients 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 patient in another clinical trial within the last four weeks before enrollment in this trial
Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism)
Pregnant or breastfeeding women
Women with childbearing potential except those who fulfill the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katrin Lorenz, Dr. | Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden | Dresden | 01307 | Germany | |||
| Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg |
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C034213 | octenidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo |
|
| After 5 days of application |
| Evaluation of taste and flavour (questionnaire) | After 5 days of application |
| AEs and SAEs | 4 weeks |
| Würzburg |
| 97070 |
| Germany |
| D009057 |
| Stomatognathic Diseases |