Influence of pH on Demineralization - Application to Oral Rinse

Objectives: We have previously reported on development of a method that would enable evaluation of demineralization potential of enamel for oral care products with lower pH (J Dent Res Vol 96B 1186, 2016). The broader application of this technique is promoted by demonstration of applicability to oral rinses. Objective: The objective of the study was to reapply simplified cycling model (SCM) to evaluate the demineralization potential of enamel for oral rinses.
Methods: Methods: Condition for the cycling method were previously described in (J Dent Res Vol 96B 1186, 2016). To assess demineralization potential of a rinse, a “non-inferiority” test is proposed. The proposed “non-inferiority” test must: a) show that the positive control (water) mean must be statistically superior to the negative control mean using a two sided 5% type I error rate, b) the test treatment mean must be statistically superior to the negative control mean using a two sided 5% type I error rate, and c) the test treatment mean must be statistically superior to the average of the positive and negative control means (non-inferiority test) using a one-sided 5% type I error rate. In other words, proven safe formulations should perform similarly (be ”non-inferior”) to the positive control (water). Because all three of the criteria must be simultaneously met for the “non-inferiority”, no multiple comparison adjustments are required. Tukey Kramer was also used to assess all multiple comparisons amongst all twelve products.
Results: Results: Ten commercial rinses with broad pH range were evaluated. Method showed good differentiation and dynamic range between water and 1% citric acid. All tested marketed products were non-inferior to water. Although one marketed rinse showed statistical differentiation when multiple comparison adjustments were applied.

Conclusions: Conclusion: This methodology is applicable for evaluation of demineralization safety of oral rinses.