Final Opinion on
The safety of dental amalgam and alternative dental restoration materials for patients and users
This opinion, which updates SCENIHR’s previous opinion of 2008, assesses the safety and effectiveness of both dental amalgam and possible alternatives, such as resin-based composites, glass ionomer cements, ceramics and gold alloys, by evaluating the scientific evidence on the potential association between amalgam and its alternatives, and allergies, neurological disorders or other adverse health effects.
A public consultation on the preliminary opinion was opened on the website of the non-food Scientific Committees from 9 September to 16 November 2014. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.
Twenty five contributors - representing industry associations, universities, professional organisations, national authorities, non-governmental organizations and individuals- participated in the public consultation providing input to the main scientific questions (in total 102 contributions were received).
Each submission was carefully considered by the SCENIHR and the scientific opinion has been revised to take account of relevant comments. The literature has been accordingly updated with relevant publications. The scientific rationale and the Opinion section were clarified and strengthened.
Content of the opinion:
The SCENIHR concludes that current evidence does not preclude the use of either amalgam or alternative materials in dental restorative treatment. However, the choice of material should be based on patient characteristics such as primary or permanent teeth, pregnancy, the presence of allergies to mercury or other components of restorative materials, and the presence of impaired renal clearance.
The SCENIHR recognises that there is a need for further research, particularly relating to (i) evaluation of the potential neurotoxicity of mercury from dental amalgam and the effect of genetic polymorphisms on mercury toxicity and (ii) to expand knowledge of the toxicity profile of alternative dental restorative materials. Furthermore, there is a need for the development of new alternative materials with a high degree of biocompatibility.
To reduce the use of mercury-added products in line with the intentions of the Minamata Convention (reduction of mercury in the environment) it can be recommended that for primary teeth alternative materials to amalgam should be the first choice. As with any other medical or pharmaceutical intervention, caution should be taken when considering the placement of any dental restorative material in pregnant women.