Preclinical and clinical assessments of calcium phosphate bone cements

Abstract

With the increasing development of biomaterials and tissue engineering, many novel biomaterials have been successfully explored. Before they are put into clinical applications, it is obligatory to appropriately and adequately evaluate the biocompatibility/biological performance in vitro and in vivo. Calcium phosphate cement (CPC), a bioactive and biodegradable grafting substance, has attracted great attention in recent years because of its self-setting and hardening after mixing the powder with a liquid phase to form a viscous paste. In order to fulfill the requirements in the clinical applications, it is necessary to make the preclinical and clinical assessments of CPC-based materials. Hence, the preclinical and clinical evaluations of biomaterials as medical devices are introduced in this chapter. The related testing protocols, standards, and guidelines are also summarized. Specifically, the biocom-patibility of CPCs is evaluated and discussed in detail. Moreover, the actual and potential clinical applications of CPCs are highlighted, particularly in the fields of oral and maxillofacial repair, cranioplasty, orthopedic applications, as well as other usages including as a drug delivery carrier and medical biosensors.