Every year in the United States, millions of animals including dogs, monkeys, rats, mice, rabbits, and cats suffer experimentation to test the biocompatibility of materials before they are used on humans. Some of the most inhumane experimentation is performed on pregnant animals. The biocompatibility screening of biomaterials is essential to protect patients from avoidable health risks; allergic reactions, treatment failure, pain and suffering, disability, and even death. All biomaterials must be evaluated according to biocompatibility screening guidelines 7405 and 10993, formulated and updated in 1997 by the International Organization for Standardization (ISO). The ISO has recommended the development of alternative biocompatibility screening methods to replace animal experimentation, but none have been developed so far.
The purpose of this project is to develop biocompatibility and embryotoxicity screening methods for biomaterials that avoid animal experimentation. This will be accomplished in the following specific aims: Specific Aim 1. We will develop the tooth slice culture technique as an alternative biocompatibility screening method to animal testing. Specific Aim 2. We will develop a stem cell culture technique as an alternative embryotoxicity screening method to animal testing. We have developed methods to maintain the survival of stem cells and to preserve the tissue structure of teeth for up to 2 weeks using in vitro tissue culture, using nutrient media and an anaerobic tissue culture incubator. The assay endpoints will be cell survival and analysis of variance statistical tests at a significance of P<0.05.
These techniques have the potential to replace many animal experiments, and allow biomaterials to be more quickly and cost effectively screened for biocompatibility. The completion of this project will provide preliminary evidence that will allow us to propose changes to the IOS biocompatibility screening guidelines to implement the use of alternative biocompatibility screening methodologies as an alternative to animal experimentation.