Efficacy of a mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride compared to a negative control mouthwash on dentin hypersensitivity reduction. A randomized clinical trial

Abstract

Objective: The objective of this eight week, single-center, two-cell, double-blind, and randomized clinical study was to evaluate the dentin hypersensitivity reduction efficacy of a mouthwash using Pro-Argin™ Mouthwash Technology containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base ("Arginine Mouthwash") compared to an ordinary mouthwash without any active ingredients ("Negative Control").

Methods: Qualifying subjects who presented two hypersensitive teeth with a tactile hypersensitivity score between 10 and 50 g of force, and an air blast hypersensitivity score of 2 or 3 participated in this study and were randomized into one of two treatment groups. Subjects brushed with the toothbrush and fluoride toothpaste provided and then rinsed with 20 mL of their assigned mouthwash for 30s twice daily. Subjects refrained from eating or drinking for 30 min after rinsing. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline visit and again after two weeks, four weeks and eight weeks of product use.

Results: Ninety (90) subjects entered and completed the eight week study. After two weeks, four weeks and eight weeks of product use, subjects in the Arginine Mouthwash group exhibited statistically significant (p<0.05) improvements in mean tactile and air blast hypersensitivity scores as compared to the Negative Control Mouthwash.

Conclusion: The results of this study support the conclusion that the Arginine Mouthwash provides a significant reduction in dentin hypersensitivity after eight weeks of product use as compared to a Negative Control mouthwash.