Dental Biomaterials: Adverse Reaction Unit

(Norwegian - Contains more information than this page)

There has been some concern about potential adverse reactions related to materials used in dental treatment. Particularly the "amalgam issue" has initiated a public interest in this field. It is evident that adverse reactions to dental materials do occur. Data on the incidence and severity is, however, not established. In 1992 the National Board of Health in Norway initiated a project with the aim to evaluate aspects of adverse reactions in the dental field. Since 1999 the "Dental Biomaterials - Adverse Reaction Unit" is a permanent activity funded by the Norwegian Government. The Unit is located at The University of Bergen, Department of Dental Biomaterials, and organized at The Bergen University Research Foundation (UNIFOB).

A large proportion of the population is exposed to dental treatment (therapeutic or prophylactic) and consequently dental materials. The number of products involved and their complexity is increasing. The discussions concerning potential adverse reactions related to the use of dental amalgam has also focused on potential side-effects from other materials, such as polymer-based filling materials and associated products, e.g. bonding agents, and cast gold alloys.

The Adverse Reaction Unit has three main purposes, described below:

1) Recording of adverse reactions

Recording forms have been sent to all Norwegian dentists as well as to hospitals and medical doctors being part of the municipal health care. The doctor is required to fill in the form and return it to the Adverse Reaction Unit when any kind of side effect is observed. Information to be recorded include general and special health status of the patient, the nature of reaction, the type of treatment involved, and information on the material(s) suspected to cause reactions. Both subjective and objective reactions can be recorded. The information is evaluated, coded and collected in a database at the Unit.

2) Clinical examination of referred patients

At the Adverse Reaction Unit patients who exhibit reactions which are suspected to be associated with dental biomaterials can be referred from the patient’s primary dental or medical doctor for additional examination. The Unit cooperates with the Department of Dermatology at Haukeland Hospital and the Department of Dental Biomaterials at the University of Bergen. Two dental doctors and one medical doctor examine the patients and the relevant background documentation received. No dental treatment is given at the Adverse Reaction Unit. The aim is to collect clinical data on the various aspects of adverse reactions, particularly those which are not directly related to local reactions.

The referral routines are designed so that the co-operation between the patient's primary medical doctor and dentist is required. Thus most of the basic information is available before the patient arrives at the Unit. One day a week is allocated to clinical examinations.

3) Information activities

The Unit should gather informational material pertaining to dental materials and their potential risks for both health personnel and the public. The Unit gathers information from other similar units, from the scientific literature and from e.g. patients' organizations.

Guidelines for dentists regarding the removal of amalgam fillings has been published in Den norske tannlegeforenings Tidende, 112th year, No. 01 - January 2002 (The journal of the Norwegian Dental Association). The aim of the guidelines is to keep mercury exposure at the lowest possible level for both patients and dental personnel during removal of amalgam fillings. The guidelines are translated to English.

Organization

The Adverse Reaction Unit started as a project at the University of Bergen in 1993. During 1998 it was reorganized as a separate permanent activity founded by the Norwegian Government (Sosial- og Helsedepartementet, from 2002 Helsedepartementet [Ministry of Health]). The Unit is a small organization with three part-time clinical positions (20-50%), an executive officer and a leader. (See the organization overview)

A Scientific Board supervises the project. The Board consists of representatives from dental, medical and psychological disciplines as well as the health authorities. The head of the Board is member of the Medical Faculty of the University of Bergen.

The Adverse Reaction Unit is organized within the UNIFOB system (an entity administratively separated from the University) at the Section for Health.