Skip to main content
OpenTrials
Completed

NCT Number: NCT02138552

Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Octenidine dihydrochloride

Drug

Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo

Placebo

Drug

Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Schülke & Mayr GmbH

Industry

Registry information

Official study title

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

Acronym: OML0113

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 14, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.