A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity

Kimberly R. Milleman, Jeffery L. Milleman, Sarah Young, Andrew Butler, Mako Araga, Mounir Atassi

Research output: Contribution to journalArticle

Abstract

Objectives
To evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse (‘Test’) for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks.

Methods
This was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders.

Results
After 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n = 43) versus the Negative Control group (n = 23) (difference: −1.22; 95% CI −1.657, −0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46 g; 95% CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n = 23) in all instances. Study products were generally well tolerated.

Conclusions
The Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent.

Clinical significance
Additional compliance features incorporated into this dentinal hypersensitivity study – recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders – appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.
Original languageEnglish
Article number100008
Number of pages7
JournalJournal of Dentistry: X
Volume2
Early online date24 Jul 2019
DOIs
Publication statusPublished - Nov 2019

Fingerprint

Hypersensitivity
Touch
Compliance
Acclimatization
Placebos
Dentifrices
Oxalic Acid
Fluorides
Air
Control Groups
Clinical Studies

Keywords

  • Dentinal hypersensitivity
  • Oral rinse
  • Potassium oxalate
  • SMS reminders
  • Text reminders

Cite this

A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity. / Milleman, Kimberly R.; Milleman, Jeffery L.; Young, Sarah; Butler, Andrew; Araga, Mako; Atassi, Mounir.

In: Journal of Dentistry: X, Vol. 2, 100008, 11.2019.

Research output: Contribution to journalArticle

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abstract = "ObjectivesTo evaluate and compare clinical efficacy of a 1.5{\%} dipotassium oxalate monohydrate (KOX)-containing oral rinse (‘Test’) for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks.MethodsThis was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders.ResultsAfter 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n = 43) versus the Negative Control group (n = 23) (difference: −1.22; 95{\%} CI −1.657, −0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46 g; 95{\%} CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n = 23) in all instances. Study products were generally well tolerated.ConclusionsThe Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent.Clinical significanceAdditional compliance features incorporated into this dentinal hypersensitivity study – recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders – appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.",
keywords = "Dentinal hypersensitivity, Oral rinse, Potassium oxalate, SMS reminders, Text reminders",
author = "Milleman, {Kimberly R.} and Milleman, {Jeffery L.} and Sarah Young and Andrew Butler and Mako Araga and Mounir Atassi",
note = "Acknowledgements The authors wish to thank all study participants and study site staff and to thank Dr Eleanor Roberts of Beeline Science Communications Ltd, London, UK for providing editorial support, which was funded by GSK Consumer Healthcare, Weybridge, UK in accordance with Good Publication Practice (GPP3) guidelines.",
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AU - Milleman, Jeffery L.

AU - Young, Sarah

AU - Butler, Andrew

AU - Araga, Mako

AU - Atassi, Mounir

N1 - Acknowledgements The authors wish to thank all study participants and study site staff and to thank Dr Eleanor Roberts of Beeline Science Communications Ltd, London, UK for providing editorial support, which was funded by GSK Consumer Healthcare, Weybridge, UK in accordance with Good Publication Practice (GPP3) guidelines.

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N2 - ObjectivesTo evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse (‘Test’) for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks.MethodsThis was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders.ResultsAfter 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n = 43) versus the Negative Control group (n = 23) (difference: −1.22; 95% CI −1.657, −0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46 g; 95% CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n = 23) in all instances. Study products were generally well tolerated.ConclusionsThe Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent.Clinical significanceAdditional compliance features incorporated into this dentinal hypersensitivity study – recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders – appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.

AB - ObjectivesTo evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse (‘Test’) for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks.MethodsThis was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders.ResultsAfter 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n = 43) versus the Negative Control group (n = 23) (difference: −1.22; 95% CI −1.657, −0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46 g; 95% CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n = 23) in all instances. Study products were generally well tolerated.ConclusionsThe Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent.Clinical significanceAdditional compliance features incorporated into this dentinal hypersensitivity study – recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders – appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.

KW - Dentinal hypersensitivity

KW - Oral rinse

KW - Potassium oxalate

KW - SMS reminders

KW - Text reminders

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DO - 10.1016/j.jjodo.2019.100008

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JO - Journal of Dentistry: X

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