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

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

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.

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)