Identification and quantification of leachable substances from polymer-based orthodontic base-plate materials.

The aim of this study was to analyse leachable monomers, additives, and degradation products from polymer-based orthodontic base-plate materials. One heat-cured resin (Orthocryl), one light-cured (Triad VLC), and three thermoplastic materials (Biocryl C, Essix A+, and Essix Embrace) were investigated. Elution was performed in water at 37°C for 10 days. The extract medium was changed and analysed daily. Chromatographic methods were used to identify and quantify the leachables. In addition, the content of residual methyl methacrylate (MMA) was quantified in the poly(methyl methacrylate) (PMMA)-based materials. Statistical analysis of the quantitative results was performed using a t-test for comparison of two independent samples. Monomers and additives leached from the materials polymerized in situ and from the thermoplastic PMMA-based material. No leachable substances were found in the extracts from the other thermoplastic materials. Accumulated over 10 days, a larger amount of MMA leached from the powder-and-liquid material, Orthocryl (42 μg/cm(2)), than from the thermoplastic material, Biocryl C (0.49 μg/cm(2)). The accumulated amounts of monomers leached from Triad VLC were 91 μg/cm(2) of urethane dimethacrylate and 2.2 μg/cm(2) of 2-hydroxyethyl methacrylate. Formaldehyde was found to leach from methacrylate-based materials: 3.2 μg/cm(2) from Orthocryl and 0.16 μg/cm(2) from Triad VLC. However, formaldehyde was not detectable in extracts from Biocryl C. Residual MMA was 5.4 wt % in Orthocryl and 0.4 wt % in Biocryl C. No phthalates were detected in the tested materials. In this in vitro study, minimal leaching was found from the thermoplastic materials, while leaching of methacrylates and formaldehyde was observed from the powder-and-liquid type and the paste material. Within the limitations of this study, the results suggest that prefabricated thermoplastic plates should be preferred for patients with an allergy to methacrylates.