Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo
- Registration Number
- NCT02138552
- Lead Sponsor
- Schülke & Mayr GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Patients with mild gingivitis (mean GI: 0.2 - 1.0)
- Patients with complete natural "Ramfjord-teeth" or their replacement teeth
- Caucasian
- Signed Informed Consent
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Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
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Patients who require endocarditis prophylaxis for dental examination and treatment
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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)
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Patients with orthodontic appliances and removable dentures
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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
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Patients chronically treated with steroids
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Patients who suffer from xerostomia
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Patients who regularly smoke more than 10 cigarettes per day
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Patients who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure
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Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
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Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism)
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Pregnant or breastfeeding women
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Women with childbearing potential except those who fulfill the following criteria:
- Post-menopausal (12 month of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
- Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- Continuous and correct application of a contraception method with a Pearl Index < 1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description OCT 0.1% vs. Placebo Placebo 0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) OCT 0.15% vs. Placebo Octenidine dihydrochloride 0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) OCT 0.1% vs. Placebo Octenidine dihydrochloride 0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) OCT 0.15% vs. Placebo Placebo 0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) OCT 2.0% vs. Placebo Octenidine dihydrochloride 0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) OCT 2.0% vs. Placebo Placebo 0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
- Primary Outcome Measures
Name Time Method Bacterial count reduction in saliva after a single application of OML in comparison to placebo application After 1 minute of rinsing Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
- Secondary Outcome Measures
Name Time Method Mean plaque index (PI) After 5 days of application PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design
Change in mean gingival index (GI) After 5 days of application GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design
Evaluation of taste and flavour (questionnaire) After 5 days of application AEs and SAEs 4 weeks
Trial Locations
- Locations (2)
Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg
🇩🇪Würzburg, Germany
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
🇩🇪Dresden, Germany