40 Novel Analysis of Gingivitis Scoring in Clinical Trials

Wednesday, March 21, 2012: 2:30 p.m. - 4 p.m.
Presentation Type: Oral Session
T.A. LISANTE, M. WU, M.W. ARAUJO, and J. GHAIM, Johnson & Johnson, CPPW, Morris Plains, NJ
Objective: The primary objective of this novel analysis was to interpret existing gingivitis data using the categorical index, the Modified Gingival Index (MGI), and determine the incidence of health over time for oral hygiene routines.

Method: 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.   Data from 3 previous  long-term studies were evaluated.  The treatment groups assessed were Brushing Alone (B), Brushing and Flossing (BF) and Brushing, Flossing and rinsing with LISTERINE® Antiseptic (BFR).

Result: At baseline of Studies 1 and 2, none of the sites in the mouth were considered healthy for the majority of subjects. For study 3, 1% of the sites were healthy for the same criteria. End of treatment data from study 1 showed an improvement for the BFR group, with a 51% incidence of ‘health’, while the B and BF groups showed 1% and 14% incidence, respectively. The incidence of ‘health’ for study 2 was 20% for BFR, 1% for BF and 0% for B. Finally, study 3 showed an incidence of ‘health’ for BFR equal to 56%, compared to 1% for the B group.

Conclusion: The results of this analysis demonstrated that adding LISTERINE® Antiseptic to a routine of brushing and flossing contributes to a substantial improvement in gingival health.

Keywords: Antimicrobials, Assessment, Clinical trials, Epidemiology and Outcome (Health)
Presenting author's disclosure statement: I am an employee of the company.