Developing a preclinical model to evaluate the results of ridge preservation techniques

Abstract

Preclinical tests required for the qualification of a biomaterial, designed for tissue-engineering approaches and regenerative medicine, for human trials are generally directed toward the evaluation of the device in animal models that approach the specific clinical application which the device is to be used. Depending on the knowledge in the field and previous data on product one can choose the appropriate model to screen the potential of the biomaterial. The protocols that are now accepted as standardized screening tests are those specific protocols which have been „validated“ through repeated use by different groups and for which consistent results were generated. Our team planned an ample preclinical research to evaluate the post-extraction healing when ridge preservation was performed using different biomaterials. Because these materials have been already tested and used in clinical practice and many data sustain their biocompatibility, we chose to perfect a canine model because: almost all preclinical studies on ridge preservation have been performed on the dog; the alveolar ridge has a similar shape to that of humans; the healing process of the extraction socket is obviously the same as humans and has already been extensively described; the roots of the experimental teeth can be easily removed. Our team studied the early healing qualitative phenomena and the late-healing qualitative and quantitative (dimensional) modifications of the ridges when different ridge preservation approaches were applied. The presented animal model that we perfected was validated by the publication of the results of our research in prestigious journals.