Keynote Address: Evidence Based Development and Clinical Implementation of Dental Biomaterials

Innovative dental biomaterials progress through a lengthy translational research process.  The development phases encompass arduous in vitro and in vivo investigations to establish products safety, efficacy and utility. The ultimate test to verify that a new product is at least as good clinically as an existing alternative is to conduct a randomized clinical trial. The RCT must have adequate statistical power, high internal and external study validities and comprise an appropriate observation period and relevant primary outcomes. For various reasons, few published trials fall under this category. The clinicians and regulators as well as industrial competitors are therefore left to make more or less grounded decisions based on syntheses of data generated from biocompatibility assessments, mechanical-physical properties tests, occasional animal experiments and perhaps sometimes preliminary clinical investigations. The extrapolation of evidence obtained under in vitro conditions to predict clinical behaviour in the intraoral environment is a classic dilemma in dental materials research. The presentation will provide an overview of current preclinical tests, of which some are established international standards. An attempt will be made to elucidate the strengths and weakness of preclinical tests in terms of more or less direct correlation to reported clinical behaviour and –performance of modern dental biomaterials.