Efficacy of New Alcohol Free Mouthrinses

University of Witten/Herdecke

Status: Completed

Conditions: Gum Disease

Treatments: Other: alcohol-free experimental mouth rinse; Other: alcohol-containing mouth rinsing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01811615

OHCMA-CHM-BUH-RHS-00633

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• handicapped participants
• allergies against mouth rinses

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups

toothbrushing plus rinsing

Active Comparator group

Description:

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

Treatment:

Other: alcohol-containing mouth rinsing

alcohol-free experimental mouth rinse

Experimental group

Description:

0.06% CHX + 0.025% NaF plus toothbrushing

Treatment:

Other: alcohol-free experimental mouth rinse

toothbrushing and rinsing

Experimental group

Description:

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

Treatment:

Other: alcohol-free experimental mouth rinse

toothbrushing alone

No Intervention group

Description:

negative control