Dental Biomaterials Adverse Reaction Reporting Following Amalgam Ban in Norway
Objectives: The Norwegian Dental Biomaterials Adverse Reaction Unit administers a nationwide system for reporting of suspected clinical biological adverse reactions related to dental biomaterials. The system aims to document all types of biological adverse reactions linked to dental biomaterials. Its primary objectives are to collect information about material-related adverse reactions and to monitor changes over time. This study aimed to investigate whether the ban on the general use of amalgam, introduced in Norway in 2008, was associated with an increase of adverse reaction reports related to alternative materials, with special emphasis on resin-based materials and cements. Methods: The reporting system is based on voluntary and spontaneous reporting from dentists, physicians, and dental hygienists. Reporting forms can be obtained from the Norwegian Dental Journal, the online platform of the Norwegian Dental Biomaterials Adverse Reaction Unit, and the most used electronic patient record software in Norway. Details from submitted adverse reaction reports are entered into a database (Microsoft Access). Reactions linked to resin-based materials and cements, metals/alloys, and materials for short-term use (<30 days) were monitored. Results: From the start in 1993 to the end of 2023 the Norwegian Dental Biomaterials Adverse Reaction Unit has received more than 2700 adverse reaction reports. The proportion of reports related to amalgam was considerably reduced after the ban of the general use of amalgam in 2008. The proportion of reports related to resin-based materials and cements and to metal/alloys has increased accordingly after 2008. However, the general amalgam ban has not resulted in an increase in the number of reports related to these materials. The proportion of reports on materials for short-term use has generally remained stable over time. Conclusions: General amalgam ban in Norway was not associated with an increase in the number of reports related to resin-based materials or to the other material categories monitored.
2024 Continental European and Scandinavian Divisions Meeting (Geneva, Switzerland) Geneva, Switzerland
2024 0041 Dental Materials 5: Biocompatibility, Bioengineering and Biologic Effects of Materials