Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: A randomised clinical in situ study

Abstract

ObjectivesTo evaluate the ability of a modified in situ model to differentiate dentinal tubule occlusion properties of toothpaste formulations over 10 days of treatment. MethodsThis was a single-centre, three-treatment period, crossover, randomised, single-blind study with healthy participants wearing two lower oral appliances, each retaining four dentine samples, for 10 treatment days during each period of the study. Samples were power-brushed ex vivo twice on each treatment day with a Test toothpaste containing 0.454% stannous fluoride, a Control fluoride toothpaste containing 0.76% sodium monofluorophosphate, or mineral water. Dentine samples were subjected to in situ acid challenge (orange juice) on Days 9 and 10. Scanning electron microscopy images obtained at baseline and after 1, 4, 8 and 10 days of treatment were graded for degree of surface coverage by four calibrated examiners; the primary study endpoint was Day 8. ResultsAfter 4, but not 8, days’ treatment, the degree of tubule occlusion increased in the dentine samples treated with the Test or Control toothpastes compared with the water-treated samples (p < 0.01 and p < 0.05, respectively). Following the acid challenge (Day 10), there was a statistically significantly greater degree of occlusion in the Test toothpaste-treated dentine samples compared with those treated with water (p < 0.01). No other comparisons were statistically significant. All study treatments were generally well-tolerated. ConclusionsThis modified in situ model was unable to demonstrate statistically significant between-treatment differences in dentinal tubule occlusion after 8 days. Conversely, there are recognised developments that could be made to better identify product differences. Clinicaltrials.gov: NCT02768194. Clinical significanceDentine hypersensitivity can be managed through brushing with stannous fluoride toothpastes, which occlude patent dentine tubules. Clinical studies measure pain but in situ models are needed to demonstrate occlusion intra-orally. However, this study did not demonstrate superior occlusion with stannous toothpaste; further methodological development is required to investigate its mode of action.