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

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

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

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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

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




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 ]


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138552


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

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

Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Octenidine
Anti-Infective Agents
Anti-Infective Agents, Local