Comparative efficacy of novel bioactive glass versus sodium fluoride toothpaste for dentin hypersensitivity: A...

This first-in-human clinical study aimed to evaluate the safety and efficacy of a bioglass incorporated in a toothpaste, in reducing dentin hypersensitivity (DH) compared to a sodium fluoride (NaF) toothpaste over a 2-week period.

A double-blind, randomized, parallel-arm, proof-of-concept clinical trial was conducted with 46 participants experiencing self-reported and clinically confirmed DH. Participants were assigned to 1 of 2 groups: (1) Test toothpaste (5 wt% bioglass with 1425 ppm fluoride as NaF), or (2) NaF toothpaste (1425 ppm fluoride). Outcomes included Schiff Airblast Sensitivity Score (primary endpoint), Visual Analog Scale (VAS) for pain, and Yeaple Probe tactile sensitivity (secondary endpoints). Statistical analyses, including analysis of covariance (ANCOVA) and descriptive statistics, were performed to evaluate intergroup differences.

The Test group exhibited a statistically significant reduction in Schiff Airblast Sensitivity Scores at Day 14 compared to the NaF group (ΔMean: -0.8 vs. -0.5, p = 0.0341). Significant improvements were also observed in VAS pain scores in as little as 2 days (ΔMean: -1.03 vs. 0.04, p = 0.0057). Rapid pain relief was noted within 2 days, indicating both immediate and cumulative effects. The difference in tactile scores was not statistically significant between groups although greater change was seen with Test toothpaste (ΔMean 13 vs. 3 g; p = 0.068). No severe adverse events were reported, and safety profiles were comparable across groups.

The toothpaste containing the bioglass demonstrated superior efficacy in alleviating DH symptoms at both early and later time points through its mechanism of rapid tubule occlusion. This innovative approach aligns with World Health Organization (WHO) recommendations for fluoride use and addresses unmet needs in DH management globally. Further research is warranted to explore its long-term applications in preventive and restorative dentistry.

U.S. National Institutes of Health Clinical Trials Registry (http://www.

gov) ID NCT06166745.