Study to Assess the Inhibition of Plaque Formation in Subjects With a Gingival Index ≤1.5

January 18, 2019 updated by: Schülke & Mayr GmbH

Randomized, Placebo-controlled, Parallel Group, Double-blind, Multi-center Phase III Study to Assess the Inhibition of Plaque Formation of 0.1% Octenidine Mouthwash vs Placebo in Subjects With a Gingival Index ≤1.5

The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period.

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.
100

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 3

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
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Poliklinik für Parodontologie der Johann Wolfgang Goethe Universität Frankfurt am Main
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Poliklinik für Parodontologie der Med. Fakultät C. G. Carus der TU Dresden
      • Leipzig, Saxony, Germany, 04103
        • Poliklinik für Zahnerhaltung und Parodontologie am Universitätsklinikum Leipzig

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult male and female subjects (aged 18 and older);
  2. Subjects with a total mean gingival index1 (GI, Löe, 1967) ≤1.5 (0.0-1.5);
  3. Subjects with at least 20 teeth (excluding wisdom teeth) with complete natural "Ramfjord-teeth" or their replacement teeth and 10 natural anterior teeth (excluding teeth provided with prosthetics such as crowns, dental bridges, veneers or large vestibular fillings such as large cervical or frontal teeth fillings; teeth with small interdental and orally oriented fillings are allowed);
  4. Non-pigmented gingiva;
  5. Signed informed consent.

Exclusion Criteria:

  1. Subjects with severe systemic diseases (e.g. hepatitis, human immunodeficiency virus [HIV] infection, tuberculosis, acute cancer treatment);
  2. Subjects who require endocarditis prophylaxis for dental examination and treatment;
  3. Subjects with caries requiring treatment (e.g. caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
  4. Subjects who have a history of chronic or aggressive periodontitis;
  5. Subjects with current moderate or severe chronic or aggressive periodontitis (periodontal screening index [PSI] >2 in more than 2 sextants or PSI >3);
  6. Subjects showing a GI score of 3 on at least one tooth;
  7. Subjects who underwent oral surgery within 14 days prior to Screening;
  8. Subjects who used antiseptic mouth rinse within 14 days prior to Screening;
  9. Subjects wearing orthodontic appliances and removable dentures (Wire-retainers after orthodontic treatment are allowed);
  10. Subjects treated with antibiotics less than 3 months prior to the baseline examination at Visit 1 and/or planning such treatment for the duration of the study;
  11. Subjects treated with systemically acting corticosteroids or corticosteroids applied via the oral cavity (e.g. asthma sprays);
  12. Subjects who suffer from xerostomia;
  13. Subjects who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure;
  14. Participation of the subject in another clinical study within the last 4 weeks before enrolment in and during this study;
  15. Incapability of assessing essence and possible consequences of the study (e.g. alcoholism);
  16. Pregnant or breastfeeding women;

  17. Women with childbearing potential except those who fulfill one of the following criteria:

    1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum follicle-stimulating hormone [FSH] >40 U/ml);
    2. Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy);
    3. Continuous and correct application of a highly effective contraception method with a Pearl Index <1% (e.g. implants, depots, oral contraceptives, intrauterine device [IUD]);
    4. Sexual abstinence; whereas sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject;
    5. Confirmation of vasectomy of the sexual partner;
  18. Evidence suggesting that the subject is not likely to follow the study protocol (e.g. lacking compliance).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
Experimental: Octenidine Mouthwash
0.1% Octenidinedihydrochlorid Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days
Drug: Octenidinedihydrochlorid
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Other Names:
  • 0.1% Octenidine Mouthwash
  • OML
Placebo Comparator: Placebo
Placebo Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days
Other: Placebo
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days

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
Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2
Time Frame: after 5 days of treatment
The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque along the gingival margin will be assessed.
after 5 days of treatment

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
Bacterial count reduction in saliva after a single administration of OML vs placebo
Time Frame: after 1 minute of rinsing
Bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration
after 1 minute of rinsing
Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2
Time Frame: baseline and after 5 days of treatment
The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4.
baseline and after 5 days of treatment
Incidence and severity of AEs (adverse events)
Time Frame: 5 days
5 days
Incidence of SAEs (serious adverse events)
Time Frame: 15 days
15 days
Change in tooth discoloration index from Visit 1 to Visit 2
Time Frame: baseline and after 5 days of treatment
baseline and after 5 days of treatment

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.
  • Principal Investigator: Katrin Lorenz, Dr.med.dent., Med. Fakultät C. G. Carus der TU Dresden, Poliklinik für Parodontologie

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 (Actual)

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.
January 22, 2018

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.
December 14, 2018

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.
December 14, 2018

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).
October 23, 2017

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.
October 23, 2017

First Posted (Actual)

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.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

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.
January 22, 2019

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.
January 18, 2019

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.
January 1, 2019

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.
  • OML-III-A
  • 2017-001697-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Drug Interventions

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