An overview of the current status of national reporting systems for adverse reactions to dental materials.
OBJECTIVE
Since all dental materials pose a potential risk to patients and members of the dental team, the post-market monitoring of adverse reactions caused by dental materials should be considered essential. This article reviews the current status of post-market monitoring of adverse reactions to dental materials and highlights some of the issues that arise in trying to establish an evidence base on the characteristics of adverse reactions to dental materials.


METHODS
Norway, Sweden and more recently the UK have sought to monitor adverse reactions to dental materials systematically and proactively in an effort to add to the evidence base on the safety of dental materials. Their experiences in undertaking post-market surveillance have been combined in preparing this article.


RESULTS
To date the Norwegian, Swedish and the UK projects has received 1268 reports over 11 years, 848 reports over 5.5 years and 1117 reports over 3 years, respectively, relating to adverse reactions seen or experienced by dental personnel and patients. Presently, there are no harmonized criteria for what can be classified as an adverse reaction related to dental materials. Under reporting is a recognised problem and lack of awareness and lack of clarity as to what constitutes an adverse reaction may be contributory factors. A pro-active reporting system takes a considerable time to become established, but can generate a lot of potentially useful information.


CONCLUSIONS
There is a need to raise the awareness among dental professionals of the potential for adverse reactions due to dental materials and to develop an internationally accepted system of data gathering that can produce the evidence that reflect the extent, severity and incidence of adverse reactions to dental materials.
van Noort
Richard
R
Department of Adult Dental Care, School of Clinical Dentistry, University of Sheffield, Sheffield S10 2TA, UK. r.vannoort@sheffield.ac.uk
Gjerdet
Nils R
NR
Schedle
Andreas
A
Björkman
Lars
L
Berglund
Anders
A
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration* / Q000706:statistics & numerical data; D000367:Age Factors; D003722:Dental Alloys / Q000009:adverse effects; D003723:Dental Amalgam / Q000009:adverse effects; D003727:Dental Auxiliaries / Q000706:statistics & numerical data; D003764:Dental Materials / Q000009:adverse effects*; D003815:Dentists / Q000706:statistics & numerical data; D016903:Drug Monitoring / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009664:Norway; D010361:Patients / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D012449:Safety; D012737:Sex Factors; D013548:Sweden; D006113:United Kingdom
D003722:Dental Alloys; D003764:Dental Materials; D003723:Dental Amalgam