Pilot clinical study to evaluate the efficacy of a professionally delivered high fluoride varnish on erosive tooth wear in an in-situ model

The aim for this pilot study was to investigate the effect of a sodium fluoride varnish on step height measured by a profilometer from human enamel worn by healthy volunteers with a novel in situ/ex vivo erosion design. Healthy volunteers aged 18–70 years wore a palatal splint containing 8 human enamel samples and underwent two 3-day treatment periods for 6 h a day with a varnish containing sodium fluoride at 22,600 ppm and the control with the same ingredients but without fluoride. Each splint contained 4 polished and 4 unpolished samples. The interventions were applied to the surface of the enamel samples in randomised order, removed after 6 h, then immersed ex-vivo in 1 %, pH 2.7 citric acid for 2 min, repeated 4 times a day, over 2 days. Measurements of enamel were assessed blindly by microhardness on day 2 and by non-contact laser profilometry on day 3 for the two treatments. 24 volunteers, 2 males and 22 females aged 27–54 years, were screened and recruited. The delta microhardness, from polished samples removed at the end of day 2, for the control and fluoride treatment was 95.7 (22.9) kgf/mm2 and 123.7 (28.9) kgf/mm2, respectively (p < .005). The mean (SD) step height for the control polished enamel surfaces was 3.67 (2.07) µm and for the fluoride varnish was 1.79 (1.01) µm (p < .0005). The control unpolished enamel surfaces had a mean 2.09 (1.53) µm and the fluoride varnish was 2.11 (1.53) µm but no statistical difference was detected. The results from this pilot study, utilizing an in-situ model where enamel was exposed to acid over the course of 2 days, demonstrated that a high fluoride varnish containing sodium fluoride at 22,600 ppm prevented erosive wear compared to a control on the polished enamel surfaces. Intra-oral study demonstrated that a high fluoride varnish containing sodium fluoride at 22,600 ppm reduced erosive tooth wear.