Proposing new standards for testing solubility of pulp preservation materials

OBJECTIVES: Quality control testing of dental materials requires a standard to enable the generation of reproducible and comparable data. Currently there are no standards for testing materials used for vital pulp therapy. The aim of this study was to develop a new standard to evaluate solubility of pulp preservation materials.

METHODS: The solubility of three materials used for vital pulp therapy: Biodentine, TheraCal and Activa was evaluated using two international standards for dental materials ISO 4049:2019 (S1) and ISO 6876:2012 (S2). For both standards, a modified methodology was evaluated. This included changing the volume of the solution used (S1M, S2M), using Dulbecco's modified eagle medium (DMEM) as an alternative to water (S1D, S2D) and periodic solution change for the ISO 4049 method (S1P, S1MP). Materials were characterised before and after completion of solubility test using scanning electron microscopy (SEM) and X-ray diffraction (XRD) analysis.

RESULTS: The test materials exhibited different solubility values depending on the methodology used. Biodentine exhibited significantly lower solubility when lower volumes of solution were used when tested using both ISO methods (p ≤ 0.05). TheraCal and Activa showed negative solubility values after desiccation when tested using ISO 4049:2019. The Biodentine exhibited changes in its microstructure which was dependent on the method used to test solubility.

CONCLUSIONS: The solubility values obtained were dependent on the method used. It is thus important to use methods that replicate the clinical environment for meaningful evaluations.