A 30-MONTH STUDY INVESTIGATING THE EFFECT OF ADDING TRICLOSAN COPOLYMER TO A FLUORIDE DENTIFRICE

The aims of the study were (1) to compare the anticaries efficacy of a silica abrasive dentifrice containing 0.24% NaF and 0.3% triclosan/2. 0% copolymer with a similar dentifrice without the triclosan/copolymer and (2) to study any disturbance of the oral mucosa associated with t he test formulation. A double-blind, random, unsupervised, 30-month lo ngitudinal clinical trial was conducted on 3,462 children who were ini tially 11-13 years of age. Two trained and calibrated dentists each ex amined approximately half the children. Examinations were undertaken a t baseline, 15 months and 30 months. No significant differences were f ound between the DFS or DFT mean increments for the two dentifrice gro ups after 15 or 30 months. At 30 months the 90% confidence interval fo r the ratio of the mean increments satisfied the ADA criteria for equi valence. It is concluded that a 0.24% NaF/silica abrasive dentifrice c ontaining 0.3% triclosan/2.0% copolymer is equivalent in its anticarie s efficacy to a similar dentifrice without the addition of triclosan/c opolymer. No side effects attributable to the test or control dentifri ces were observed at any time during the study.