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Efficacy of New Alcohol Free Mouthrinses

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ClinicalTrials.gov Identifier: NCT01811615
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
PD Dr. A. Rainer Jordan, University of Witten/Herdecke

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gum Disease Other: alcohol-free experimental mouth rinse Other: alcohol-containing mouth rinsing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
Study Start Date : February 2010
Actual Primary Completion Date : February 2011

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



Primary Outcome Measures :
  1. Modified Proximal Plaque Index (MPPI) [ Time Frame: Eight weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • handicapped participants
  • allergies against mouth rinses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811615


Locations
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Germany
Witten/Herdecke University School of Dental Medicine
Witten, NRW, Germany, 58455
Sponsors and Collaborators
University of Witten/Herdecke
GlaxoSmithKline
Investigators
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Study Director: Stefan Zimmer, Professor Witten/Herdecke University

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Responsible Party: PD Dr. A. Rainer Jordan, Head of Section Preclinical Dentistry, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT01811615     History of Changes
Other Study ID Numbers: OHCMA-CHM-BUH-RHS-00633
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs