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

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Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste : a randomised clinical in situ study. / West, Nicola; Seong, Joon; Hellin, Nicola; Macdonald, Emma; Jones, Sian; Creeth, Jon.

In: Journal of Dentistry, Vol. 76, 09.2018, p. 125-131.

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@article{8a030542f4974726bdc5109c92398a22,
title = "Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: a randomised clinical in situ study",
abstract = "fluoride toothpaste: a randomised clinical in situ study Objectives: To evaluate the ability of a modified in situ model to differentiate dentinal tubule occlusion properties of toothpaste formulations over 10 days of treatment. Methods: This 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. Results: After 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. Conclusions: This 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 significance: Dentine 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.",
keywords = "crossover, Dentine Hypersensitivity, Dentineal tubule occlusion, in situ model, Stannous fluoride, toothpaste",
author = "Nicola West and Joon Seong and Nicola Hellin and Emma Macdonald and Sian Jones and Jon Creeth",
year = "2018",
month = "9",
doi = "10.1016/j.jdent.2018.07.001",
language = "English",
volume = "76",
pages = "125--131",
journal = "Journal of Dentistry",
issn = "0300-5712",
publisher = "Elsevier",

}

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TY - JOUR

T1 - Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste

T2 - a randomised clinical in situ study

AU - West, Nicola

AU - Seong, Joon

AU - Hellin, Nicola

AU - Macdonald, Emma

AU - Jones, Sian

AU - Creeth, Jon

PY - 2018/9

Y1 - 2018/9

N2 - fluoride toothpaste: a randomised clinical in situ study Objectives: To evaluate the ability of a modified in situ model to differentiate dentinal tubule occlusion properties of toothpaste formulations over 10 days of treatment. Methods: This 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. Results: After 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. Conclusions: This 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 significance: Dentine 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.

AB - fluoride toothpaste: a randomised clinical in situ study Objectives: To evaluate the ability of a modified in situ model to differentiate dentinal tubule occlusion properties of toothpaste formulations over 10 days of treatment. Methods: This 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. Results: After 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. Conclusions: This 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 significance: Dentine 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.

KW - crossover

KW - Dentine Hypersensitivity

KW - Dentineal tubule occlusion

KW - in situ model

KW - Stannous fluoride

KW - toothpaste

U2 - 10.1016/j.jdent.2018.07.001

DO - 10.1016/j.jdent.2018.07.001

M3 - Article

VL - 76

SP - 125

EP - 131

JO - Journal of Dentistry

JF - Journal of Dentistry

SN - 0300-5712

ER -