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

Gingivitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138552
• Other study ID #: 2013-002708-14
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2013
• Last updated: May 12, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Schülke & Mayr GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

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

Locations

Country	Name	City	State
Germany	Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden	Dresden
Germany	Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Schülke & Mayr GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean plaque index (PI)	PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design	After 5 days of application	No
Secondary	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	After 5 days of application	No
Secondary	Evaluation of taste and flavour (questionnaire)		After 5 days of application	No
Secondary	AEs and SAEs		4 weeks	Yes