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

• ClinicalTrials.gov Identifier: NCT02138552
• Recruitment Status: Completed
• First Posted: May 14, 2014
• Last Update Posted: May 14, 2014
• Sponsor: Schülke & Mayr GmbH
• Information provided by (Responsible Party): Schülke & Mayr GmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gingivitis	Drug: Octenidine dihydrochloride; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: October 2013
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Bacterial count reduction in saliva after a single application of OML in comparison to placebo application [ Time Frame: 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 Outcome Measures :

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

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Germany

Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden

Dresden, Germany, 01307

Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg

Würzburg, Germany, 97070

Sponsors and Collaborators

Schülke & Mayr GmbH

Investigators

• Study Director: Katrin Lorenz, Dr.; Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden

More Information

• Responsible Party: Schülke & Mayr GmbH
• ClinicalTrials.gov Identifier: NCT02138552
• Other Study ID Numbers: 2013-002708-14
• First Posted: May 14, 2014
• Last Update Posted: May 14, 2014
• Last Verified: May 2014

Additional relevant MeSH terms:

Gingivitis; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Octenidine; Anti-Infective Agents; Anti-Infective Agents, Local