Clinical Efficacy on Stain Prevention of Fluoride/KNO₃/Small Particle Silica Toothpaste

Objectives: The aim of this double-blind clinical study was to assess stain prevention efficacy for two products (1) a toothpaste that contains 1100 ppm F as NaF, 5% KNO3 and 10% small particle silica that is specially formulated to remove and prevent surface stains (Test) and (2) Colgate Cavity Protection Toothpaste (Negative Control).
Methods: Following baseline examinations of Lobene stain index (LSI) and soft and hard tissues, qualified subjects were randomized into two groups (Test and Negative Control), which were balanced for LSI scores. After baseline examinations, prophylaxis was performed. Then subjects were instructed to brush twice daily (morning and evening) for 1 minute each time. Examinations of LSI scores were conducted again after three and six weeks of product use.
Results: After the clinical protocol was approved by an IRB, one-hundred (100) subjects entered the clinical study, and 98 out of 100 complied with the protocol and completed the six-week study. The mean Lobene composite statin scores for Test group at post-prophy baseline, three and six weeks were 0.00, 0.65 and 0.92, respectively, and for the Negative Control group at post-prophy baseline, three and six weeks were 0.00, 0.90 and 1.35, respectively. Thus, Test group provided statistically significant more stain prevention reductions than Colgate Cavity Protection Toothpaste at three weeks (27.8%) and six weeks (31.9%).
Conclusions: The clinical study supported that the Fluoride/KNO3/Small Particle Silica Toothpaste provided statistically significant more statin prevention reduction than Colgate Cavity Protection Toothpaste at three and six weeks.