Clinical trial NCT02138552: Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo
Official title: Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Lead sponsor: Schülke & Mayr GmbH
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
timeFrame: After 1 minute of rinsing
Secondary outcomes:
measure: Mean plaque index (PI)
timeFrame: After 5 days of application
measure: Change in mean gingival index (GI)
timeFrame: After 5 days of application
measure: Evaluation of taste and flavour (questionnaire)
timeFrame: After 5 days of application
measure: AEs and SAEs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
city: Würzburg
country: Germany
facility: Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg
Study officials:
affiliation: Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
name: Katrin Lorenz, Dr.
role: STUDY_DIRECTOR
References: