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

Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Octenidine dihydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
  • Würzburg, Germany, 97070
    • Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCT 0.1% vs. Placebo; 0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)	Drug: Octenidine dihydrochloride; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo; Drug: Placebo; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Active Comparator: OCT 0.15% vs. Placebo; 0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)	Drug: Octenidine dihydrochloride; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo; Drug: Placebo; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Active Comparator: OCT 2.0% vs. Placebo; 0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)	Drug: Octenidine dihydrochloride; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo; Drug: Placebo; Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application	Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design	After 1 minute of rinsing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean plaque index (PI)	PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design	After 5 days of application
Change in mean gingival index (GI)	GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design	After 5 days of application
Evaluation of taste and flavour (questionnaire)		After 5 days of application
AEs and SAEs		4 weeks

Collaborators and Investigators

• Sponsor: Schülke & Mayr GmbH
• Investigators: Study Director: Katrin Lorenz, Dr., Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Octenidine
• Other Study ID Numbers: 2013-002708-14