Therapeutic effect of a novel bioactive glass-ceramics on early caries lesions: a single-center, randomized controlled clinical trial

Objectives To investigate the therapeutic effect of a novel bioactive glass-ceramics (BGC) called Huaxi BGC (HX-BGC) on early caries lesions. Materials and methods A total of 195 patients who meeting inclusion criteria were recruited and randomized to three groups in a 1:1:1 ratio. The patients in the treatment group received fluoride varnish which contained 5% sodium fluoride (NaF) or distilled water which contained 7.5% HX-BGC once a month for 3 months, and the control group received placebos. Quantitative light-induced fluorescence (QLF) images were taken at baseline and at the 1-month and 3-month follow-ups. Results The three groups had similar baseline characteristics, including age, gender, and QLF parameters (Delta F, area, and Delta Q). Compared with baseline, the Delta Q values were significantly decreased in the HX-BGC and NaF groups at 1 and 3 months (p<0.005), while no statistically significant changes were found in that of the control group. After adjusting for baseline measurements, both of the 5% NaF and 7.5% HX-BGC showed a significant therapeutic effect in the treatment of initial enamel lesions at 1 month and 3 months, when compared to those receiving placebos (Delta Q, p<0.05). Moreover, the Delta Q value of the HX-BGC group decreased by a slightly more amount than that of the NaF group at 1 month (p=0.048). Similar trends were also found for the values of Delta F and area. Conclusion Our results suggest that HX-BGC may serve as a promising bioactive material for the treatment of early caries lesions.