Clinical studies - site-wise analysis (Sharma)

Site-wise analysis of adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study²

Objective

Determine the incremental benefit of the adjunctive use of an essential oil-containing antiseptic mouthrinse (LISTERINE®COOL MINT®) to routine brushing and flossing on the incidence of health over time of each gingival site (N=237).

Methodology

Post-hoc analysis of the Sharma 2004 study, a randomized, controlled, observer-blind, parallel-group clinical study of subjects with mild-to-moderate gingivitis.  The MGI scores the gingiva on a scale of 0-4 (absence to severe inflammation). During categorization, the index was split into two categories: scores 0 or 1 (generally healthy, very mild to no inflammation) and >=2 (mild to severe inflammation). For each treatment at a timepoint, the percent of subjects scored ‘healthy’ was plotted by site and the incidence of ‘Health’ among the 108 sites, defined as the number of sites where a majority (>50%) of subjects scored healthy, was calculated. The treatment groups assessed were Brushing Alone (B), Brushing and Flossing (BF) and Brushing, Flossing and rinsing with LISTERINE® Antiseptic (BFR).

Modified Gingival Index (MGI)

Results

Adding LISTERINE^® Antiseptic resulted in 2x more healthy gingival sites versus brushing and flossing alone.¹