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

May 12, 2014 updated by: Schülke & Mayr GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
After 1 minute of rinsing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
After 5 days of application
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
After 5 days of application
Evaluation of taste and flavour (questionnaire)
Time Frame: After 5 days of application
After 5 days of application
AEs and SAEs
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schülke & Mayr GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Katrin Lorenz, Dr., Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-002708-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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