An 18-week home-use study comparing the oral hygiene and gingival health benefits of triclosan and fluoride toothpastes.

Several triclosan and stannous fluoride toothpastes have been shown to have plaque inhibitory and more particularly gingival health benefits when compared to minus active controls. There have been relatively few studies to compare such products with conventional fluoride toothpastes in home use. The aim of this study was to compare the relative gingival health benefits of a triclosan/zinc citrate, triclosan/copolymer, stannous fluoride and conventional fluoride toothpastes in a home use study. The study was a double blind, parallel design with a total 143 healthy dentate volunteers (41 male, 102 female) who toothbrushed 2x daily with 1 of 4 toothpastes over an 18 week period. At the beginning of the trial, each volunteer was scored for plaque and gingivitis and then received a thorough prophylaxis. Each volunteer was allocated a toothpaste according to a predetermined randomisation scheme. The volunteers were then re-examined after 6, 12 and 18 weeks. No other oral hygiene products were used during this period. The results showed no statistically significant treatment differences between products for the gingival index throughout the 18 week-trial. No statistically significant treatment effects between products for plaque index were found at 6 or 18 weeks. However, a small but statistically significant treatment effect for plaque index was seen at 12 weeks in favour of the triclosan/copolymer toothpaste compared to the stannous fluoride and conventional fluoride toothpastes, this difference had disappeared by the 18 week examination. All volunteers oral hygiene and gingivitis scores improved after the baseline examination, and this improvement continued throughout the trial. This is a feature of nearly all toothbrushing studies and can be attributed to the initial prophylaxis and the Hawthorne phenomenon. Such phenomena, noted in home use clinical trials, may mask the efficacy of proven antiplaque formulations.

RCT Entities:   Population Interventions Outcomes