Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin®) in providing rapid dentine hypersensitivity relief

John Gallob,Martin R Ling,Pejmon Amini,Avinash Patil,Mounir Atassi

doi:10.1016/j.jjodo.2019.100003

Abstract

ObjectiveTo evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). MethodsIn this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10min, 2h and 4h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. ResultsAt 10min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (−0.46; 95% confidence intervals [CI]: −0.563, −0.356; p<0.0001) but not with No treatment (−0.02; 95% CI: −0.119, 0.088; p=0.7664). The between-treatment group difference favored the Test strip (difference: −0.44; 95% CI: −0.591, −0.297; p<0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p<0.0001 vs no-treatment) at all timepoints (10min, 2h, 4h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as “like moderately” (40%) or “like extremely” (20%). There were no treatment-related adverse events. ConclusionThis new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). Clinical significanceA dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10min, may provide rapid relief from dentine hypersensitivity.

Highlights

Dentine hypersensitivity (DH) is characterized by a transient and sharp burst of pain arising from exposed cervical dentine in response to external thermal, evaporative, tactile, osmotic or chemical stimuli, not attributed to other forms of dental defect or disease [1]
The first participant was enrolled in November 2016; the final participant completed the study in December 2016
Study groups were well balanced at baseline (Table 1)

Summary

Introduction

Dentine hypersensitivity (DH) is characterized by a transient and sharp burst of pain arising from exposed cervical dentine in response to external thermal, evaporative, tactile, osmotic or chemical stimuli, not attributed to other forms of dental defect or disease [1]. The hydrodynamic theory of DH proposes that exposure of dentine to an external stimulus causes fluid movement within dentinal tubules [5] If these tubules are patent from the pulp to the oral environment [1], the dentinal shift activates nerve terminals near the tubule base, eliciting a pain response [6]. This theory has led to development of two approaches to DH management: physical occlusion of exposed ends of dentinal tubules, which reduces fluid shift and subsequent nociceptor activation, or use of desensitizing agents such as potassium nitrate, which are believed to reduce intradental nerve excitability [7]

Methods

Results

Conclusion