Efficacy of New Alcohol Free Mouthrinses

NCT ID: NCT01811615

Last Updated: 2013-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

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.

Detailed Description

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Conditions

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Gum Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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toothbrushing plus rinsing

0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing

Group Type ACTIVE_COMPARATOR

alcohol-containing mouth rinsing

Intervention Type OTHER

alcohol-free experimental mouth rinse

0.06% CHX + 0.025% NaF plus toothbrushing

Group Type EXPERIMENTAL

alcohol-free experimental mouth rinse

Intervention Type OTHER

toothbrushing and rinsing

0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing

Group Type EXPERIMENTAL

alcohol-free experimental mouth rinse

Intervention Type OTHER

toothbrushing alone

negative control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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alcohol-free experimental mouth rinse

Intervention Type OTHER

alcohol-containing mouth rinsing

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. A. Rainer Jordan

Head of Section Preclinical Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Germany

Other Identifiers

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OHCMA-CHM-BUH-RHS-00633

Identifier Type: -

Identifier Source: org_study_id

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