A total of 159 adult male and female subjects between 18 and 63 years of age, were entered into a 6-month, double-blind clinical study to assess the effects of a
dentifrice containing 0.3%
triclosan and 2% of a copolymer of methoxyethylene and
maleic acid on supragingival plaque formation and
gingivitis, as compared to a placebo
dentifrice. Both the
triclosan and placebo
dentifrices contained 0.243%
sodium fluoride in a
silica base. The subjects had to demonstrate at least mild
gingivitis (modified Loe-Silness score > or = 1.0), be free of advanced
periodontal disease, have a modified Quigley-Hein Plaque Index score of at least 1.5 and have a minimum of 20 natural, uncrowned teeth. The subjects were stratified into two balanced groups according to baseline plaque and
gingivitis scores. At zero time or baseline, all subjects received a complete and thorough oral prophylaxis and were assigned to the use of either the placebo
dentifrice or the
triclosan/copolymer
dentifrice for the next 6 months. Subjects were evaluated for
gingivitis and supragingival plaque formation after 3 and 6 months product use. After 3 months, when compared to the placebo
dentifrice, the
triclosan/copolymer
dentifrice provided the following statistically significant reductions (at 99% confidence levels): (1) a 10.0% reduction in supragingival plaque formation; (2) a 20.8% reduction in plaque formation on tooth surfaces with highest baseline plaque scores; (3) a 21.9% reduction in
gingivitis, and (4) 30.5% less sites with severe
gingivitis, i.e. gingival
bleeding.(ABSTRACT TRUNCATED AT 250 WORDS)