The safety and biocompatibility of direct aesthetic restorative materials.

ABSTRACT

Restorative dental materials are among the most important medical devices in terms of the numbers of patients who benefit and the technical sophistication of the products. Many though contain toxic or noxious substances, including potentially sensitising resin monomers, photoinitiators, acidic polymers and glass or ceramic filler particles. Despite this, dental materials are among the safest medical devices in use today, with very few reports of adverse reactions or injuries among both patients or the dental team. This paper considers the potential for adverse reactions to dental materials, current evidence for harm and finally examines the reasons why in real-world clinical use the likelihood of an adverse event is extremely low. Medical devices regulations, responsible manufacture and clinical vigilance all appear to play important roles in ensuring that dental materials do not cause or present a risk to patients. While this excellent in-practice safety record is welcome, there is now increasing interest in the 'macro' scale biocompatibility of dental materials and their packaging in the environment, subjects that have been relatively neglected until recently. It was concluded that this should be a priority for future research and development and support is needed from governments alongside the manufacturing industry and the profession.