Gm. Hawley et al., A 30-MONTH STUDY INVESTIGATING THE EFFECT OF ADDING TRICLOSAN COPOLYMER TO A FLUORIDE DENTIFRICE, Caries research, 29(3), 1995, pp. 163-167
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.