Gum Disease Clinical Trial
Official title:
A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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