Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Octenidine dihydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild gingivitis (mean GI: 0.2 - 1.0) Patients with complete natural Ramfjord-teeth or their replacement teeth Caucasian Signed Informed Consent 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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCT 0.1% vs. Placebo<br>0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) | Drug: Octenidine dihydrochloride<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>Drug: Placebo<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>|
| Active Comparator: OCT 0.15% vs. Placebo<br>0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) | Drug: Octenidine dihydrochloride<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>Drug: Placebo<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>|
| Active Comparator: OCT 2.0% vs. Placebo<br>0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) | Drug: Octenidine dihydrochloride<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>Drug: Placebo<br>* Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | After 5 days of application | 
| Evaluation of taste and flavour (questionnaire) |  | After 5 days of application | 
| AEs and SAEs |  | 4 weeks |