Abstract

Aims: To demonstrate the effective delivery to gingival tissues of the gum health actives zinc citrate and vitamin E acetate from a new silica based fluoride toothpaste and to confirm the clinical efficacy of the full formulation in vivo. Methods: Study 1: Zinc levels were measured from plaque samples immediately before and 10 minutes after brushing with the new toothpaste and compared to a similar marketed zinc containing product; Study 2: Vitamin E acetate levels were measured from the new toothpaste by swabbing gum tissues immediately after brushing; Study 3: Vitamin E acetate delivery and penetration of porcine gingival tissue ex vivo was measured and compared to delivery of the agent from an already marketed product; Study 4: The effect of the new toothpaste on gingival condition after three months home use was investigated in comparison to a marketed 0.3% triclosan containing toothpaste. Results: The new toothpaste showed significantly higher levels of zinc delivery compared to a similar marketed toothpaste. Vitamin E acetate delivery was also shown to be effective from both the in vivo and ex vivo studies. Clinically, both the new formulation and the 0.3% Triclosan control showed significant reduction in gingivitis after 12 weeks home use. Conclusions: Zinc citrate and vitamin E acetate are delivered at effective levels to gum tissue from the new formulation. The in vivo efficacy of the formulation has been demonstrated, showing the new toothpaste to be an effective anti-gingivitis formulation.

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