A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
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
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
Intervention: alcohol-containing mouth rinsing (Other)
alcohol-free experimental mouth rinse
0.06% CHX + 0.025% NaF plus toothbrushing
Intervention: alcohol-free experimental mouth rinse (Other)
toothbrushing and rinsing
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
Intervention: alcohol-free experimental mouth rinse (Other)
toothbrushing alone
negative control
Outcomes
Primary Outcomes
Modified Proximal Plaque Index (MPPI)
Time Frame: Eight weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
PD Dr. A. Rainer Jordan
Head of Section Preclinical Dentistry
University of Witten/Herdecke
