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

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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

Keywords

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

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