Stain control with two modified stannous fluoride/sodium tripolyphosphate toothpastes: A randomised controlled proof...

To compare build-up of extrinsic tooth stain following use of two novel anhydrous stannous fluoride/sodium tripolyphosphate (SnF₂/STP) toothpastes with adjusted (lower) relative dentin abrasivities (RDAs) versus a marketed control and a reference toothpaste.

Following prophylaxis, 220 adults with extrinsic dental stain on anterior teeth facial surfaces were randomised to 4 weeks' twice-daily brushing with either novel 0.454% w/w SnF₂ (1100ppm fluoride)/5% w/w STP toothpastes with differing levels of abrasive silica: 'Test RDA∼58'; 'Test RDA∼77', or a reference: 'Ref RDA∼80' (1000ppm fluoride from sodium monofluorophosphate) or marketed control toothpaste: 'Ref RDA∼120' [0.454% w/w SnF₂ (1100ppm fluoride)/5% w/w STP]. Primary endpoint was total Macpherson modification of the Lobene Stain Index (MLSI) area×intensity (A×I) score at Week 4 for Test toothpastes versus Ref RDA∼80. Secondary endpoints were total MLSI (A×I) for all toothpastes versus Ref RDA∼120.

After 4 weeks, mean total MLSI scores for Test RDA∼58, Test RDA∼77 and Ref RDA∼80 were all lower than Ref RDA∼120. Ranking order of performance for controlling stain build-up was: Test RDA∼77 > Test RDA∼58 > Ref RDA∼80 > Ref RDA∼120. There was no statistical difference between Test RDA∼58 and Ref RDA∼80; Test RDA∼77 was statistically lower than RDA∼80. All toothpastes were generally well-tolerated.

This study showed low levels of stain build-up after 4 weeks' twice-daily use of novel, low abrasivity, anhydrous SnF₂ toothpaste formulations (RDA∼58, RDA∼77), similar to marketed toothpastes (RDA∼80; RDA∼120). Lowering the RDA of appropriately formulated SnF₂ toothpastes therefore may not negatively impact stain build-up potential (Clinicaltrials.gov NCT03160703).

This study indicates lowering RDA of an anhydrous SnF₂ toothpaste does not appear to negatively impact its overall dental stain control potential. Development of appropriately formulated SnF₂ toothpastes with lower abrasivity may have additional benefits for individuals with dentin hypersensitivity by managing potential dentin wear.