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Completed

NCT Number: NCT01811615

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Witten/Herdecke University School of Dental Medicine

Witten, North Rhine-Westphalia, 58455, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • handicapped participants
  • allergies against mouth rinses

Treatment and study plan

alcohol-free experimental mouth rinse

Other

alcohol-containing mouth rinsing

Other

Primary outcomes

  1. Modified Proximal Plaque Index (MPPI)

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Mar 14, 2013
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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