OBJECTIVE: To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control. METHODS: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use. RESULTS:One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.
RCT Entities:
OBJECTIVE: To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control. METHODS: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use. RESULTS: One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.
Authors: Ruth G Ledder; Joe Latimer; Gavin J Humphreys; Prem K Sreenivasan; Andrew J McBain Journal: Appl Environ Microbiol Date: 2014-08-08 Impact factor: 4.792