Publication:

A multicentric observational single arm study to evaluate the effectiveness of toothpaste containing fluoro calcium phosphosilicate (Biomin) in the long-term relief of dentine hypersensitivity

Background Dentin hypersensitivity (DH) is an acute, transient pain from exposed dentin in response to stimuli not attributable to other dental defects or diseases. Among treatment options, fluoro-calcium phosphosilicate (Biomin) toothpaste has shown promising results in recent studies. The objective was to evaluate the long-term effectiveness, safety, and tolerability of Biomin toothpaste in Indian patients with DH.

Methods This was a prospective, investigator-initiated, multicenter, single-arm, open-label, observational study. Patients used the investigational toothpaste (Hydent Pro) twice daily for 24 weeks. Endpoints included changes in SCASS, VAS pain scores, DHEQ-15, gingival health and supra-gingival plaque scores. Safety and tolerability were monitored throughout.

Results A total of 121 patients (male: female, 71:50; mean age, 41.1 years) were enrolled. At week 24 significant (p<00.001) reductions were observed in SCASS (−1.8), VAS (−57.9), DHEQ-15 (−51.3) scores, and both mean Gingival health and supra-gingival-plaque scores also declined significantly (p<0.001) by -1.8, respectively. Investigators rated the effectiveness and tolerability of the toothpaste as excellent to very good in 89.9% and 92.5% patients respectively. No adverse events or other pharmacovigilance relevant information were reported.

Conclusion Twenty-four weeks of Biomin toothpaste treatment resulted in significant sensitivity relief. Improved overall oral-health-related quality of life; gingival health and anti-plaque action highlight its long-term therapeutic value. Moreover, 24 weeks of treatment with Biomin toothpaste was well-tolerated and can be an effective therapeutic option in the management of DH.