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Title

Clinical Studies - Site-wise Analysis (Sharma)

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).

Site-Wise Analysis

Subjects were randomized to one of three groups:

  • Brushing + Hydroalcohol (5%) Rinse
  • Brushing + Flossing + Hydroalcohol (5%) Rinse
  • Brushing + Flossing + LISTERINE® Antiseptic

Following a complete prophylaxis on Day 1, subjects were instructed to:

  • Rinse with 20 mL of their assigned rinse for 30 seconds 2x daily
  • 6 month period
  • Brush 2x daily + Floss 1x day (day the two groups that included floss)

Plaque, gingivitis, and bleeding assessments were conducted at:

  • Baseline
  • Month 3
  • Month 6

 

Modified gingival index

Modified gingival index (MGI)

HEALTHY UNHEALTHY
0 1 2 3 4
No inflammation Mild inflammation of any portion of the gingival unit (slight change in colour, little change in texture) Mild inflammation of the entire gingival site Moderate inflammation (moderate glazing, redness, edema, and/or enlargement of the gingival unit) Severe inflammation (marked redness edema, and/or enlargement, spontaneous bleeding or ulceration of the qinqival unit

 

Results

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

Maxillary marginal sites
Maxillary proximal sites
Mandibular marginal sites
Mandibular proximal sites

Conclusion

This long-term study demonstrates that the adjunctive use of an essential oils-containing mouthrinse twice daily provides 2x more healthy gingival sites versus brushing and flossing alone.1