Opportunities for caries prevention using an ion-releasing coating material: a randomised clinical study.

Ion-releasing materials (containing fluoride and boron, for example) have shown caries-preventive effects in vitro. The purpose of the present study was to investigate the impact of multi-ion-releasing coating material on pH stabilisation, plaque accumulation and the bacterial composition of dental plaque during a time period of 90 days. The null hypothesis tested here was that the evaluated material would not show any differences in pH stabilisation, plaque accumulation or bacterial composition compared with control material.The study was carried out as a double-blind, split-mouth, randomised, controlled clinical trial in 28 volunteers. Over the evaluation period (days 4, 30, 60 and 90), pH measurements, plaque index and plaque sampling for bacterial analyses were conducted in a calibrated, standardized manner. The study received ethical permission and was carried out in accordance with the Helsinki Declaration.A significant difference was observed, with less plaque accumulation over time in the subjects in whom the ion-releasing material was applied in comparison to the non-active group. No significant difference was evident in terms of either pH stabilisation or plaque levels of mutans streptococci.The null hypothesis relating to plaque accumulation was rejected, with a lower plaque index shown for the test group up to 60-90 days. No adverse effects during the observation period were observed. Since the studied cohort was healthy from a caries perspective, more clinical studies are needed to further evaluate the caries-prevention potential of the ion-releasing material in other patient groups.

RCT Entities:   Population Interventions Outcomes