Efficacy of New Alcohol Free Mouthrinses

March 13, 2013 updated by: PD Dr. A. Rainer Jordan, University of Witten/Herdecke

A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses

Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.

Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

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
    • NRW
      • Witten, NRW, Germany, 58455
        • Witten/Herdecke University School of Dental Medicine

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participants between 18 and 65 years
  • no severe periodontitis
  • informed consent

Exclusion Criteria:

  • handicapped participants
  • allergies against mouth rinses

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: toothbrushing plus rinsing
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
Other: alcohol-containing mouth rinsing
Experimental: alcohol-free experimental mouth rinse
0.06% CHX + 0.025% NaF plus toothbrushing
Other: alcohol-free experimental mouth rinse
Experimental: toothbrushing and rinsing
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
Other: alcohol-free experimental mouth rinse
No Intervention: toothbrushing alone
negative control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Proximal Plaque Index (MPPI)
Time Frame: Eight weeks
Eight weeks

Collaborators and Investigators

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

Sponsor

University of Witten/Herdecke

Collaborators

GlaxoSmithKline

Investigators

  • Study Director: Stefan Zimmer, Professor, Witten/Herdecke University

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

February 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHCMA-CHM-BUH-RHS-00633

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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