Gingivitis
Conditions
Brief summary
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.
Interventions
DRUGOctenidine dihydrochloride
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
DRUGPlacebo
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Sponsors
Schülke & Mayr GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial count reduction in saliva after a single application of OML in comparison to placebo application | After 1 minute of rinsing | Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean plaque index (PI) | After 5 days of application | PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design |
| Change in mean gingival index (GI) | After 5 days of application | GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design |
| Evaluation of taste and flavour (questionnaire) | After 5 days of application | — |
| AEs and SAEs | 4 weeks | — |
Countries
Germany
Outcome results
None listed