A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation

OBJECTIVES: Phytate is an organic, cyclic polyphosphate analogous to linear condensed polyphosphates used as stain removal agents. This study investigated stain removal efficacy of an experimental sodium phytate‐containing dentifrice compared to a reference dentifrice. METHODS: An experimental, moderate abrasivity (relative dentine abrasivity [RDA] ∼130) antisensitivity fluoride dentifrice containing sodium phytate (0.85% w/w as the hexasodium salt) (n = 111) was compared to a reference, marketed, low‐abrasivity (RDA ∼ 43), anti‐sensitivity fluoride dentifrice (n = 113), both containing 1150 ppm fluoride as sodium fluoride. Primary efficacy variables were between‐treatment differences in extrinsic dental stain of anterior teeth after 6 and 12 weeks' twice‐daily use, using Lobene stain index (MacPherson modification, MLSI) mean area (A) and intensity (I) scores. Comparisons included whole‐tooth and hard‐to‐reach areas (gingival, interproximal, body of lingual). RESULTS: At both 6‐ and 12‐week timepoints, MLSI (A × I) scores for total area and hard‐to‐reach areas for the experimental dentifrice were statistically significantly lower than baseline (P < .0001 for all). This was demonstrated for the reference dentifrice at 6 weeks only, for total, interproximal (P < .0001 for both), and body of lingual (P = .0395) scores. Compared with the reference, the experimental dentifrice had statistically significantly lower MLSI scores at both 6 and 12 weeks for all outcome variables including both total MLSI (A × I) and hard‐to reach areas (P < .0001 in all cases). Products were generally well‐tolerated. CONCLUSIONS: Differences between treatments were considered clinically differentiable. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation. CLINICAL SIGNIFICANCE: Following 6 and 12 weeks brushing, clinically differentiable differences were shown in stain index scores with an experimental dentifrice containing sodium phytate compared to a reference dentifrice without sodium phytate. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.