search
Back to results

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

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Octenidine dihydrochloride
Placebo
Sponsored by
Schülke & Mayr GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
  • Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

OCT 0.1% vs. Placebo

OCT 0.15% vs. Placebo

OCT 2.0% vs. Placebo

Arm Description

0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)

Outcomes

Primary Outcome Measures

Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design

Secondary Outcome Measures

Mean plaque index (PI)
PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design
Change in mean gingival index (GI)
GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design
Evaluation of taste and flavour (questionnaire)
AEs and SAEs

Full Information

First Posted
November 11, 2013
Last Updated
May 12, 2014
Sponsor
Schülke & Mayr GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT02138552
Brief Title
Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo
Acronym
OML0113
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schülke & Mayr GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT 0.1% vs. Placebo
Arm Type
Active Comparator
Arm Description
0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
Arm Title
OCT 0.15% vs. Placebo
Arm Type
Active Comparator
Arm Description
0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
Arm Title
OCT 2.0% vs. Placebo
Arm Type
Active Comparator
Arm Description
0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
Intervention Type
Drug
Intervention Name(s)
Octenidine dihydrochloride
Intervention Description
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
Primary Outcome Measure Information:
Title
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
Description
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
Time Frame
After 1 minute of rinsing
Secondary Outcome Measure Information:
Title
Mean plaque index (PI)
Description
PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design
Time Frame
After 5 days of application
Title
Change in mean gingival index (GI)
Description
GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design
Time Frame
After 5 days of application
Title
Evaluation of taste and flavour (questionnaire)
Time Frame
After 5 days of application
Title
AEs and SAEs
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Lorenz, Dr.
Organizational Affiliation
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
Official's Role
Study Director
Facility Information:
Facility Name
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg
City
Würzburg
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs