Predicting clinical biological responses to dental materials

Area of Science:

• Biomaterials Science
• Dental Materials
• Toxicology

Background:

• Assessing biological responses to dental materials is challenging, with existing methods for safety evaluation being controversial and often unsuccessful.
• The definition of biocompatibility has evolved from simple inertness to encompass complex roles in oral health care.

Purpose of the Study:

• To review significant issues in assessing the biological safety of dental materials.
• To provide a historical summary and critical analysis of the biocompatibility literature.
• To emphasize the global importance of these issues in dental material evaluation.

Main Methods:

• Searched PubMed, U.S. Food and Drug Administration, International Standards Organization, and American National Standards Institute databases.
• Focused on literature from 1965-2011 concerning biocompatibility definitions, biological tests, and regulatory standards.
• Highlighted significant issues rather than conducting a comprehensive literature review.

Main Results:

• Past notions of material inertness as the sole measure of safety are now considered naive.
• Debates continue regarding the use of in vitro and animal tests for predicting clinical safety.
• Controlled clinical trials are the best measure of clinical response but have limitations; practice-based research networks are emerging as supplements.

Conclusions:

• Dental materials are increasingly used for sophisticated structural and therapeutic functions.
• Strategies for assessing, predicting, and monitoring material safety must evolve to meet these new demands.
• The evolution of safety assessment will involve researchers, manufacturers, patients, and practitioners.