Objective: This single blind, crossover design, clinical trial provided a comparative assessment of the oral cleaning of two dental devices as demonstrated through the removal of dental plaque when used according to marketed product-use directions.
Methodology: Twenty-six subjects, both male and female between the ages of 19 and 64 years, completed this two-cell crossover study. Subjects were assessed for whole mouth plaque levels, both before and after use of each of the randomly assigned floss devices, by assessing disclosed plaque using the Modified Turesky Plaque Index. The two floss devices were a Mint Floss Pick and a stan- dard rolled floss. Subjects abstained from brushing the night before appearing in the clinic, and based upon meeting the minimum plaque criteria of 1.5 at the first phase of the crossover, used one of the two floss devices according to the directions for use found on the product packaging. Both pre- and post-device use plaque levels were recorded with calculations made of both the actual difference in plaque level, as well as the percent plaque removed. Data were subjected to an analysis of covariance (ANCOVA), and employed a model consistent with crossover design.
Results: Overall results from both phases of the crossover showed the Mint Floss Pick product removed 19.4% of the plaque. The standard rolled floss product removed 15% of the plaque. Both products removed statistically significant plaque when assessed versus pre-treatment levels. Although the ANCOVA identified a statistically significant difference between treatments favoring the Floss Pick product, further statistical examination revealed a significant sequence effect, which led to a conservative product comparison of equivalence. This analysis confirmed that the Floss Pick product was “at least as good as” the standard floss product for plaque removal. Additional analyses of various sites in the mouth, i.e., interproximal, anterior, posterior, etc., also confirmed similarity of performance for both products in this test.
Conclusion: A two-way crossover assessment of the cleaning capability of a Mint Floss Pick product compared to a standard rolled floss product was performed through assessment of the removal of dental plaque. Results of this clinical investigation support the Floss Pick product to be “at least as good as” standard rolled floss in cleaning capability when both products were used according to their product-use directions.Download