Study Results
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Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2010-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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toothbrushing plus rinsing
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
alcohol-containing mouth rinsing
alcohol-free experimental mouth rinse
0.06% CHX + 0.025% NaF plus toothbrushing
alcohol-free experimental mouth rinse
toothbrushing and rinsing
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
alcohol-free experimental mouth rinse
toothbrushing alone
negative control
No interventions assigned to this group
Interventions
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alcohol-free experimental mouth rinse
alcohol-containing mouth rinsing
Eligibility Criteria
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Inclusion Criteria
* no severe periodontitis
* informed consent
Exclusion Criteria
* allergies against mouth rinses
18 Years
65 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
University of Witten/Herdecke
OTHER
Responsible Party
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PD Dr. A. Rainer Jordan
Head of Section Preclinical Dentistry
Principal Investigators
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Stefan Zimmer, Professor
Role: STUDY_DIRECTOR
Witten/Herdecke University
Locations
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Witten/Herdecke University School of Dental Medicine
Witten, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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OHCMA-CHM-BUH-RHS-00633
Identifier Type: -
Identifier Source: org_study_id
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