Abstract
Objectives: To evaluate the ability of a modified in-situ model to differentiate the dentinal tubule occlusion properties of toothpaste formulations after 1, 4, 8 (primary objective) and 10 days of treatment.
Methods: This was a single-centre, three-treatment period, crossover, randomised, single-blind study in which healthy participants wore two lower oral appliances for 10 days per treatment period. Each appliance held four dentine samples, which were replaced for each treatment period. The samples were power-brushed ex-vivo twice on each treatment day with a test toothpaste containing 0.454% stannous fluoride, a conventional fluoride toothpaste containing 0.76% sodium monofluorophosphate or water. Dentine samples were subjected to in-situ acid challenge (orange juice) on Days 9 and 10. On days 1, 4, 8 and 10, one sample was removed from each appliance and imaged using scanning electron microscopy. Images were graded for occlusion (0–5) by four calibrated examiners. Change from baseline in mean occlusion classification score was calculated using Mixed Model Repeated Measures analysis.
Results: Twenty-one of 24 participants randomised to study treatments completed all three treatment periods. After 4 days’ treatment, the degree of tubule occlusion statistically significantly increased for the samples treated with the test (p=0.0023) or conventional (p=0.0194) toothpastes compared with the water-treated samples. Following the acid challenge (Day 10), there was a statistically significantly greater degree of occlusion in the test toothpaste treated samples compared with those treated with water (p=0.0058). No other between-treatment differences, including at day 8, were statistically significant. Study treatments were generally well tolerated.
Conclusions: In this study, the modified in-situ model did not demonstrate statistically significant differences between toothpastes in dentinal tubule occlusion. The model requires further development to improve differentiation between products.
Methods: This was a single-centre, three-treatment period, crossover, randomised, single-blind study in which healthy participants wore two lower oral appliances for 10 days per treatment period. Each appliance held four dentine samples, which were replaced for each treatment period. The samples were power-brushed ex-vivo twice on each treatment day with a test toothpaste containing 0.454% stannous fluoride, a conventional fluoride toothpaste containing 0.76% sodium monofluorophosphate or water. Dentine samples were subjected to in-situ acid challenge (orange juice) on Days 9 and 10. On days 1, 4, 8 and 10, one sample was removed from each appliance and imaged using scanning electron microscopy. Images were graded for occlusion (0–5) by four calibrated examiners. Change from baseline in mean occlusion classification score was calculated using Mixed Model Repeated Measures analysis.
Results: Twenty-one of 24 participants randomised to study treatments completed all three treatment periods. After 4 days’ treatment, the degree of tubule occlusion statistically significantly increased for the samples treated with the test (p=0.0023) or conventional (p=0.0194) toothpastes compared with the water-treated samples. Following the acid challenge (Day 10), there was a statistically significantly greater degree of occlusion in the test toothpaste treated samples compared with those treated with water (p=0.0058). No other between-treatment differences, including at day 8, were statistically significant. Study treatments were generally well tolerated.
Conclusions: In this study, the modified in-situ model did not demonstrate statistically significant differences between toothpastes in dentinal tubule occlusion. The model requires further development to improve differentiation between products.
| Original language | English |
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| Publication status | Accepted/In press - 4 Apr 2018 |
| Event | 96th General Session of the IADR, 2018 - Excel London Convention Centre, London, United Kingdom Duration: 25 Jul 2018 → 28 Jul 2018 Conference number: 96 http://www.iadr.org/IADR/Meetings/2018IAGS |
Conference
| Conference | 96th General Session of the IADR, 2018 |
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| Country/Territory | United Kingdom |
| City | London |
| Period | 25/07/18 → 28/07/18 |
| Internet address |