Efficacy of New Alcohol Free Mouthrinses

Study Overview
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Brief Summary
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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.

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

Conditions
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Gum Disease

Intervention / Treatment
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* Other: alcohol-free experimental mouth rinse
* Other: alcohol-containing mouth rinsing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants between 18 and 65 years no severe periodontitis informed consent Exclusion Criteria: handicapped participants allergies against mouth rinses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Proximal Plaque Index (MPPI) |  | Eight weeks |