[Neon-colored plastics for orthodontic appliances. Biocompatibility studies]

Public concern and issues of liability have made product safety a major concern throughout the medical field including orthodontics. The purpose of this study was to test the biocompatibility of the new neon colored plastic materials to be used for removable orthodontic appliances before they reach the market and are used in patient treatment. In addition, eight modifications of this synthetic material, which has been used in appliances for many years, were examined without neon color. The procedures established tested for: 1. mutagenicity, 2. toxicity, and 3. irritation of the mucous membrane. As alternatives to using animals the Ames Test, the Agar Overlay Assay, and the HET-CAM Test were employed to test for these properties. The tests revealed that, when the manufacturer's instructions are followed, neither the polymerized materials as used in patient appliances nor the shavings resulting from the orthodontist or the technician grinding the appliance exhibit mutagenic, toxic, or irritating properties.