Efficacy of New Alcohol Free Mouthrinses
A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
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
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedMarch 14, 2013
March 1, 2013
1 year
January 18, 2013
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Modified Proximal Plaque Index (MPPI)
Eight weeks
Study Arms (4)
toothbrushing plus rinsing
ACTIVE COMPARATOR0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
alcohol-free experimental mouth rinse
EXPERIMENTAL0.06% CHX + 0.025% NaF plus toothbrushing
toothbrushing and rinsing
EXPERIMENTAL0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
toothbrushing alone
NO INTERVENTIONnegative control
Interventions
Eligibility Criteria
You may qualify if:
- participants between 18 and 65 years
- no severe periodontitis
- informed consent
You may not qualify if:
- handicapped participants
- allergies against mouth rinses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Witten/Herdeckelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Witten/Herdecke University School of Dental Medicine
Witten, North Rhine-Westphalia, 58455, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stefan Zimmer, Professor
Witten/Herdecke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Section Preclinical Dentistry
Study Record Dates
First Submitted
January 18, 2013
First Posted
March 14, 2013
Study Start
February 1, 2010
Primary Completion
February 1, 2011
Last Updated
March 14, 2013
Record last verified: 2013-03