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

Launched by SCHÜLKE & MAYR GMBH · May 12, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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)