Efficacy of a novel dentifrice containing bioactive glass-ceramic for dentinal hypersensitivity: A double-blind randomized controlled trial in Chinese adults.

OBJECTIVE:To assess the efficacy and safety of a toothpaste containing 7.5 % HX-BGC in combating dentinal hypersensitivity. METHODS:A single-center, randomized, double-blind, three-group parallel-controlled design was employed, with Schiff Index and Yeaple Index as measurement indicators. The study evaluated the effectiveness of HX-BGC toothpaste, NovaMin toothpaste, and a negative control toothpaste without desensitizing agents. Eligible subjects underwent baseline examination after a 2-week washout period, and those meeting inclusion criteria and not meeting exclusion criteria entered the study. Participants were randomly assigned to use one of the three toothpastes. Follow-up examinations were conducted immediately after a single use and at 2, 4, and 6 weeks. Intra-group and inter-group comparisons were made for Schiff and Yeaple indices. Safety of the experimental toothpastes was assessed through participant feedbacks and oral soft tissue examinations. RESULTS:Subjects in the three groups were balanced in terms of age and gender distribution, with no baseline differences in indicators. Immediately after a single application of toothpaste, Yeaple indices increased, and Schiff indices decreased, with no significant differences among the groups. After 2 weeks of continuous use, Yeaple indices increased in all groups, with significant differences observed between the HX-BGC group and the other two groups. Schiff indices decreased in all groups, with the NovaMin group showing significant differences compared to the negative control group. At weeks 4 and 6, both indices in the HX-BGC group and the NovaMin group were significantly better than those in the negative control group, with the HX-BGC group outperforming the NovaMin group in the Yeaple index. No serious adverse reactions related to the study products were observed or reported by any participants. CLINICAL SIGNIFICANCE:This clinical trial confirmed the efficacy of HX-BGC in anti-dentinal hypersensitivity and supported the clinical application of the dentifrice containing HX-BGC. CONCLUSION:Compared to the negative control group, both HX-BGC and NovaMin toothpaste groups demonstrated more significant effects in combating dentinal hypersensitivity. No adverse reactions related to the experimental toothpastes were observed.