Phase II study to assess bacterial count reduction of three Octenidine mouthwash concentrations in comparison to a placebo in patients with mild gingivitis

Conditions: patients aged 18 and older with mild gingivitis
MedDRA version: 14.1Level: PTClassification code 10018292Term: GingivitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

Registration Number: EUCTR2013-002708-14-DE

Lead Sponsor: Schülke & Mayr GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Adult male and female patients (aged 18 and older)
•Patients who have mild gingivitis (mean GI: 0.2 - 1.0)
•Patients with complete natural Ramfjord-teeth” or their replacement teeth
•Caucasian
•Patients must have signed the informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to placebo;Secondary Objective: Safety and effects on other parameters, such as Plaque-Index and Gingival Index;Primary end point(s): The primary endpoint of this trial is the bacterial count reduction in saliva after a single application of OML in comparison to placebo application at V1 and V3.;Timepoint(s) of evaluation of this end point: Visit 1 (Baseline, Day 0) and Visit 3 (18 or 21 days later than Baseline)

Secondary Outcome Measures