Efficacy of New Alcohol Free Mouthrinses

Gum Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811615
• Other study ID #: OHCMA-CHM-BUH-RHS-00633
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: March 13, 2013
• Start date: February 2010

Study information

• Verified date: March 2013
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• participants between 18 and 65 years

• no severe periodontitis

• informed consent

Exclusion Criteria:

• handicapped participants

• allergies against mouth rinses

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gum Disease

Intervention

Other:
• alcohol-free experimental mouth rinse

• alcohol-containing mouth rinsing

Locations

Country	Name	City	State
Germany	Witten/Herdecke University School of Dental Medicine	Witten	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University of Witten/Herdecke	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Proximal Plaque Index (MPPI)		Eight weeks	No