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Clinical Trials/NCT01811615
NCT01811615CompletedNot Applicable

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

University of Witten/Herdecke2 sites in 1 country160 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
160
Locations
2
Primary Endpoint
Modified Proximal Plaque Index (MPPI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • handicapped participants
  • allergies against mouth rinses

Arms & Interventions

toothbrushing plus rinsing

Active Comparator

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

Intervention: alcohol-containing mouth rinsing (Other)

alcohol-free experimental mouth rinse

Experimental

0.06% CHX + 0.025% NaF plus toothbrushing

Intervention: alcohol-free experimental mouth rinse (Other)

toothbrushing and rinsing

Experimental

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

Intervention: alcohol-free experimental mouth rinse (Other)

toothbrushing alone

No Intervention

negative control

Outcomes

Primary Outcomes

Modified Proximal Plaque Index (MPPI)

Time Frame: Eight weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

PD Dr. A. Rainer Jordan

Head of Section Preclinical Dentistry

University of Witten/Herdecke

Study Sites (2)

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