patients aged 18 and older with mild gingivitis MedDRA version: 14.1 Level: PT Classification code 10018292 Term: Gingivitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Octenidine mouthwash
Pharmaceutical Form: Mouthwash
INN or Proposed INN: OCTENIDINE DIHYDROCHLORIDE
CAS Number: 70775-75-6
Concentration unit: % (W/V) percent weight/volume
Concentration
Sponsors
Schülke & Mayr GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Bacterial count reduction in saliva after use of OML in comparison to placebo mouthwash at V2 and V4 • Bacterial counts in saliva before application at V1 compared to V2 for all mouthwash groups. • Bacterial counts in saliva before application at V3 compared to V4 for all mouthwash groups. • Mean plaque index (PI) at V2 and V4 • Change in mean gingival index (GI) between V1/V2 and V3/V4, respectively • Evaluation of taste and flavour (questionnaire) • AEs and SAEs ;Timepoint(s) of evaluation of this end point: Bacterial count reduction in saliva after use of OML in comparison to placebo mouthwash at V2 and V4 • Bacterial counts in saliva before application at V1 compared to V2 for all mouthwash groups. • Bacterial counts in saliva before application at V3 compared to V4 for all mouthwash groups. • Mean plaque index (PI) at V2 and V4 • Change in mean gingival index (GI) between V1/V2 and V3/V4, respectively • Evaluation of taste and flavour (questionnaire) • AEs and SAEs | — |
Countries
Germany
Contacts
Public ContactBarbara Djawid
Koordinierungszentrum für Klinische Studien an der TU Dresden
Outcome results
None listed