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 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 (93/42/EEC).
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.
The main aim of the activity is to gain knowledge about experienced adverse reactions to dental materials in Norway.
The reporting procedure is based on spontaneous and voluntary reporting from dentists, physicians, and dental hygienists. A special reporting form is regularly published in the journal of the Norwegian Dental Association and is also available from the internet pages.
The reports include information regarding the patient’s gender, age, general diseases, current medication, known allergies, symptoms and signs, type of dental treatment, and materials suspected to cause the reaction. An assessment, made by both the reporter and the patient, of the association between the exposure to the dental material and the reaction is also included.
Whenever a possible adverse reaction is experienced, the clinician should submit the reporting form even if there is doubt regarding the causality.
Adverse reaction reports received at the Unit are recorded in a database (MS Access) and analyzed with regard to the materials involved using multiple response analysis on a yearly basis.
When detailed information on the used materials is included in the report (product name and manufacturer), the reporter is requested to send information about the reaction to the manufacturer as well.
From January 1, 2005, dentists who report adverse reactions to the Unit are reimbursed by the Norwegian Health Economics Administration.
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.
The Norwegian national manufacturer-independent reporting procedure provides longitudinal data concerning suspected adverse reactions associated with dental biomaterials.
The reporting from health professionals concerning adverse reactions or adverse events in the form of a dedicated reporting procedure can reveal changes in adverse reaction patterns and serve as a signal-generating tool in combination with a specialized clinical examination.
Voluntary reporting combined with specialized examination can be used to complement the general vigilance reporting procedure and post-marketing surveillance by the manufacturers.
(Reference: Björkman L, Gjerdet NR, Lygre GB, Berge TLL, Svahn J, Lundekvam BF. National reporting of adverse reactions to dental biomaterials in Norway J Dent Res, Vol. 93, (Spec Iss C): 599, 2014.
Scheme for reporting adverse reactions
Only available in Norwegian.
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