NCT02138552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

November 11, 2013

Last Update Submit

May 12, 2014

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • 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

    After 1 minute of rinsing

Secondary Outcomes (4)

  • Mean plaque index (PI)

    After 5 days of application

  • Change in mean gingival index (GI)

    After 5 days of application

  • Evaluation of taste and flavour (questionnaire)

    After 5 days of application

  • AEs and SAEs

    4 weeks

Study Arms (3)

OCT 0.1% vs. Placebo

ACTIVE COMPARATOR

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

Drug: Octenidine dihydrochlorideDrug: Placebo

OCT 0.15% vs. Placebo

ACTIVE COMPARATOR

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

Drug: Octenidine dihydrochlorideDrug: Placebo

OCT 2.0% vs. Placebo

ACTIVE COMPARATOR

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

Drug: Octenidine dihydrochlorideDrug: Placebo

Interventions

Octenidine dihydrochlorideDRUG

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

OCT 0.1% vs. PlaceboOCT 0.15% vs. PlaceboOCT 2.0% vs. Placebo
PlaceboDRUG

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

OCT 0.1% vs. PlaceboOCT 0.15% vs. PlaceboOCT 2.0% vs. Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild gingivitis (mean GI: 0.2 - 1.0)
  • Patients with complete natural "Ramfjord-teeth" or their replacement teeth
  • Caucasian
  • Signed Informed Consent

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Dresden, 01307, Germany

Location

Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg

Würzburg, 97070, Germany

Location

MeSH Terms

Conditions

Gingivitis

Interventions

octenidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Katrin Lorenz, Dr.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

May 14, 2014

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

DE(2)