Adverse reactions to dental biomaterials: Experiences from a specialty clinic

Abstract

Objectives The Dental Biomaterials Adverse Reaction Unit was initiated by the Norwegian health authorities in 1992 as a response to the public concern regarding the safety of dental amalgam and other dental materials. In this paper, experiences from the Unit are briefly summarized. Methods The Norwegian health authorities’ strategy included four main topics: (i) development of a manufacturer-independent system for monitoring adverse reactions related to dental materials, (ii) funding of a specialty unit for clinical examinations of referred patients, (iii) development of official guidelines for examination and treatment of patients with health complaints attributed to dental materials, and (iv) funding of an experimental treatment project for patients with health complaints attributed to dental amalgam. Results From the start, more than 2700 adverse reaction reports were received. In the initial years, amalgam was the most frequent material mentioned in the reports. Reports about polymer-based composite materials have not increased after the prohibition of amalgam in Norway. Clinical examination of referred patients is complex and time consuming, and it is important to consider differential diagnoses. There are methodological challenges associated with the design of experimental treatments used on patients with adverse reactions attributed to dental materials. However, the results from the treatment project indicate lower symptom load after replacement of amalgam with other dental restorative materials. Significance Producer independent adverse reaction reporting can provide valuable information about the safety of these materials and could serve as a complement to the mandatory reporting system described in the European medical device regulations (MDR).