How to qualify and validate wear simulation devices and methods.

Abstract

The clinical significance of increased wear can mainly be attributed to impaired aesthetic appearance and/or functional restrictions. Little is known about the systemic effects of swallowed or inhaled worn particles that derive from restorations. As wear measurements in vivo are complicated and time-consuming, wear simulation devices and methods had been developed without, however, systematically looking at the factors that influence important wear parameters. Wear simulation devices shall simulate processes that occur in the oral cavity during mastication, namely force, force profile, contact time, sliding movement, clearance of worn material, etc. Different devices that use different force actuator principles are available. Those with the highest citation frequency in the literature are - in descending order - the Alabama, ACTA, OHSU, Zurich and MTS wear simulators. When following the FDA guidelines on good laboratory practice (GLP) only the expensive MTS wear simulator is a qualified machine to test wear in vitro; the force exerted by the hydraulic actuator is controlled and regulated during all movements of the stylus. All the other simulators lack control and regulation of force development during dynamic loading of the flat specimens. This may be an explanation for the high coefficient of variation of the results in some wear simulators (28-40%) and the poor reproducibility of wear results if dental databases are searched for wear results of specific dental materials (difference of 22-72% for the same material). As most of the machines are not qualifiable, wear methods applying the machine may have a sound concept but cannot be validated. Only with the MTS method have wear parameters and influencing factors been documented and verified. A good compromise with regard to costs, practicability and robustness is the Willytec chewing simulator, which uses weights as force actuator and step motors for vertical and lateral movements. The Ivoclar wear method run on the Willytec machine shows a mean coefficient of variation in vertical wear of 12%. Force measurements have revealed that in the beginning of the stylus/specimen contact phase the force impulse is 3-4 times higher during dynamic loading than during static loading. When correlating material properties to the wear results of 23 composite resins subjected to the Ivoclar method, some parameters could be identified and incorporated into a wear formula to predict wear with the Ivoclar method. A round robin test evaluating the wear of ten dental materials with five wear simulation methods showed that the results were not comparable, as all methods follow different wear testing concepts. All wear methods lack the evidence of their clinical relevance because prospective studies correlating in vitro with long-term in vivo results with identical materials are not available. For direct restorative materials, amalgam seems to be a realistic reference material. For indirect, namely crown and bridge materials, low strength ceramic is appropriate.