Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo (OML0113)

Schülke & Mayr

Status and phase: Completed; Phase 2

Conditions: Gingivitis

Treatments: Drug: Placebo; Drug: Octenidine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02138552

2013-002708-14

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

OCT 0.1% vs. Placebo

Active Comparator group

Description:

0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

Treatment:

Drug: Octenidine dihydrochloride

Drug: Placebo

OCT 0.15% vs. Placebo

Active Comparator group

Description:

0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

Treatment:

Drug: Octenidine dihydrochloride

Drug: Placebo

OCT 2.0% vs. Placebo

Active Comparator group

Description:

0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

Treatment:

Drug: Octenidine dihydrochloride

Drug: Placebo