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Time-course of clinical efficacy of a 5% calcium-sodium phosphosilicate toothpaste on dentine hypersensitivity
Jonathan Creeth1, Chhaju Ram Goyal2, Jianhong Qiu3
1Haleon, St George's Avenue, Weybridge KT13 0DE, United Kingdom.
Objectives:
Anhydrous toothpastes containing 5% calcium-sodium phosphosilicate (CSPS) have well-established long-term efficacy against dentine hypersensitivity (DH). However, short-term efficacy is not well-characterised. This study investigated the degree of DH reduction over 3-56 days' twice-daily brushing with a 5% CSPS toothpaste and also explored user-reported impact on oral health-related quality-of-life (OHRQoL), via a DH Experience Questionnaire (DHEQ-48).
Methods:
This single-centre, 8-week, randomized, controlled, examiner-blind, 2 treatment-arm, stratified, parallel-design clinical study evaluated DH reduction from a twice-daily brushing regimen using a 5% w/w CSPS toothpaste containing NaF (Test), compared to a regimen using a conventional NaF-silica toothpaste (Reference), in an orally-healthy DH population. Two non-adjacent teeth with clinically confirmed DH were selected. DH was assessed, by Schiff score (evaporative stimulus) and Tactile threshold (Yeaple probe), at Baseline and after 3d, 7d, 14d, 28d and 56d. DHEQ experience questionnaires were completed at 28d and 56d.
Results:
217 participants were screened; 215 completed the study. The Test regimen significantly reduced examiner-assessed DH at all post-Baseline timepoints for both efficacy measures (p < 0.0001); these changes were significantly greater than those observed from the Reference regimen (all p < 0.001). DH reduction from the Test regimen markedly increased during the study. DHEQ scores in the Test group decreased progressively through the study, although treatment-related differences did not reach statistical significance.
Conclusions:
Treatment with the 5% CSPS anhydrous toothpaste reduced DH compared to a marketed NaF-silica toothpaste, by 2 clinically-assessed measures. DH reduction was significant after 3 days, growing progressively over 8 weeks. Treatments were generally well-tolerated. Registration #NCT06378008 (Clinicaltrials.gov).
Clinical Significance:
A 5% calcium-sodium phosphosilicate toothpaste provided dentine hypersensitivity relief amongst sufferers within 3d; relief progressively increased over time, demonstrating its effectiveness as a treatment option.
