Clinical comparison of mouthrinse and orodispersible film containing cystatins and a statherin-derived peptide against initial dental erosion.

This randomized crossover in vivo study compared the anti-erosive efficacy of solution and orodispersible film (ODF) formulations containing three cystatins (CaneCPI-5, MaquiCPI-3, and CsinCPI-2) combined with a statherin-derived peptide (StN15pSpS). Ten participants completed six experimental phases: negative controls (water or placebo ODF), positive controls (Elmex or NaF-containing ODF), and experimental formulations (solution or ODF containing proteins/peptide). After prophylaxis and baseline surface reflection intensity (SRI) measurement, treatments were applied (1 min), followed by acquired enamel pellicle formation (2 h), an erosive challenge (15 s), and final SRI assessment. Calcium release was determined by Arsenazo III method. Questionnaires evaluating satisfaction, preference, and safety were also applied. Two-way anova showed a significant treatment effect, but no effect of vehicle or treatment-vehicle interaction (p < 0.05). Both experimental formulations yielded higher percentage SRI values than their respective negative controls. The experimental ODF outperformed the NaF-ODF, whereas the experimental solution was comparable to Elmex. The experimental ODF reduced calcium release compared with placebo, whereas the experimental solution did not differ from water and released more calcium than Elmex. Participants preferred the ODF, considering it more practical and convenient. Both formulations prevented initial dental erosion in vivo, with the ODF showing promising efficacy and greater user acceptance.