National Reporting of Adverse Reactions to Dental Biomaterials in Norway
From 1993, the Norwegian Dental Biomaterials Adverse Reaction Unit has operated a national reporting procedure concerning suspected biologic adverse reactions experienced in relation to treatment with dental biomaterials. The procedure is based on spontaneous and voluntary reporting from dentists, physicians, and dental hygienists. The reporting is designed to record all types of adverse reactions and is not limited to serious events described in the reporting procedures based on the European medical devices directive. From January 2008, the use of dental amalgam, along with other mercury-containing products, was heavily restricted, and later prohibited (December 2010) by Norwegian authorities due to environmental concerns. In reality, resin-based materials (composites) and cements became the only choice of materials for direct dental restorations. Objective: To gain knowledge about material-associated adverse reactions and to monitor changes over time. Method: Adverse reaction reports were analyzed with regard to the types of materials involved using multiple response analysis on a yearly basis. The following categories were analyzed: Dental amalgam, composites and cements, metals and alloys, and materials for short term use. Result: From 1993 to the end of 2013, more than 2100 reports have been received. The proportion of reports involving dental amalgam decreased from a peak of 89 % in 1994 to 40 % in 2013. In 2013, 28 % of the reports were related to composites and cements, a ratio that has remained relatively stable over the years following the amalgam ban. The proportion of reports including reactions involving metals and alloys increased from 13 % in 1993 to 32 % in 2013. Conclusion: The Norwegian national manufacturer-independent reporting procedure provides longitudinal data concerning suspected adverse reactions experienced in relation to treatment with dental biomaterials. Acknowledgement: The Norwegian Dental Biomaterials Adverse Reaction Unit is funded by the Norwegian Directorate of Health.
Division: Pan European Region Meeting
Meeting:2014 Pan European Region Meeting (Dubrovnik, Croatia) Location: Dubrovnik, Croatia
Year: 2014 Final Presentation ID:599 Abstract Category|Abstract Category(s):Scientific Groups
Authors
Björkman, Lars
( Uni Research AS, Bergen, , Norway
)
Gjerdet, Nils Roar
( University of Bergen, Bergen, N/A, Norway
)
Lygre, Gunvor B.
( Uni Research AS, Bergen, , Norway
)
Berge, Trine Lise Lundekvam
( Uni Research AS, Bergen, , Norway
)
Svahn, Johanna
( Uni Research AS, Bergen, N/A, Norway
)
Lundekvam, Birgitte F.
( Uni Research AS, Bergen, N/A, Norway
)
SESSION INFORMATION
Poster Session
Results of Health Services
09/13/2014