Completed

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

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What is being tested

alcohol-containing mouth rinsing

+ alcohol-free experimental mouth rinse

+ alcohol-free experimental mouth rinse

Other
Who is being recruted

Stomatognathic Diseases+1

+ Mouth Diseases

+ Periodontal Diseases

From 18 to 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2010
See protocol details

Summary

Principal SponsorUniversity of Witten/Herdecke
Last updated: March 14, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Witten/Herdecke
Last updated: March 14, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesPeriodontal DiseasesGingival Diseases

Criteria

3 inclusion criteria required to participate
informed consent

no severe periodontitis

participants between 18 and 65 years

2 exclusion criteria prevent from participating
allergies against mouth rinses

handicapped participants

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
0.06% CHX + 0.025% NaF plus toothbrushing

Group III

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

Group IV

No Intervention
negative control

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Witten/Herdecke University School of Dental Medicine

Witten, GermanyOpen Witten/Herdecke University School of Dental Medicine in Google Maps
CompletedOne Study Center