A six-month, double-blind clinical study was entered into by three hundred twenty-five (325) male and female adult subjects to assess the efficacy of a
dentifrice containing 0.3%
triclosan (Irgacare MP, Ciba-Geigy Corp.) and 2.0% of a copolymer of methoxyethylene and
maleic acid (
Gantrez, ISP Corp.) on supragingival plaque formation and
gingivitis, compared to a placebo
dentifrice over a six-month period. Each
dentifrice, the
triclosan and the placebo, contained 0.243%
sodium fluoride in a
silica base. Only those subjects who were free of
periodontal disease (no pockets > 4 mm), demonstrated a level of at least mild
gingivitis (modified Loe-Silness score > or = 1.0) and had a modified Quigley-Hein Plaque Index score of > or = 1.5 were admitted into the study. Baseline plaque and
gingivitis scores were used to stratify the subjects into two balanced groups. A thorough oral prophylaxis was administered to all subjects. They were then assigned either the
triclosan/copolymer
dentifrice or the placebo
dentifrice to use for the next six months. Evaluation for
gingivitis and supragingival plaque formation was made after three and six months. Evaluations made after six (6) months demonstrated a 17.0% statistically significant (at the 99% level of confidence) reduction in supragingival plaque formation was provided by the
triclosan/copolymer
dentifrice, compared to the placebo
dentifrice. An 18.6% statistically significant (at the 99% level of confidence) reduction in plaque formation on the tooth surfaces with the highest plaque formation was provided by the
triclosan/copolymer
dentifrice, compared to the placebo
dentifrice.(ABSTRACT TRUNCATED AT 250 WORDS)