AM Pfarrer, RL Karlinsey. Challenges of implementing new remineralization technologies. Advances in Dental Research 21, 79 (2009)
There are increasing numbers of promising technologies aimed at enhancing tooth remineralization or preventing tooth decay, yet relatively few technologies are brought to market with substantiated claims of anti-caries performance, even when favorable clinical performance has been established. Clinical trials are often viewed as the biggest challenge encountered during the development of new agents; however, there are additional and substantial challenges encountered during product development and market introduction. The aim of this paper is to provide some insight into the various challenges that might be encountered during the development of new anti-caries technologies. Such challenges may exist in formulation development, performance relative to clinically proven technologies, statistical analysis of data, and regulatory requirements.
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