Efficacy of New Alcohol Free Mouthrinses

Not Applicable

Completed

• Conditions: Gum Disease
• Interventions: Other: alcohol-containing mouth rinsing; Other: alcohol-free experimental mouth rinse

• Registration Number: NCT01811615
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-02
• Study First Submitted: 2013-01-18
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-13
• Last Update Submitted: 2013-03-13
• Study First Posted: 2013-03-14
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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Exclusion Criteria

• handicapped participants
• allergies against mouth rinses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toothbrushing plus rinsing	alcohol-containing mouth rinsing	0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
toothbrushing and rinsing	alcohol-free experimental mouth rinse	0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
alcohol-free experimental mouth rinse	alcohol-free experimental mouth rinse	0.06% CHX + 0.025% NaF plus toothbrushing

Primary Outcome Measures

Name	Time	Method
Modified Proximal Plaque Index (MPPI)	Eight weeks

Trial Locations

Locations (1)

Witten/Herdecke University School of Dental Medicine; 🇩🇪 Witten, NRW, Germany