Assessing the biocompatibility of a dental composite product

Objective: The purpose of the study was to assess the biocompatibility of a composite material considering the reaction caused at the implant site during 21 days by daily observing the subjects' behavior as well as by macroscopic examination and histological examination upon expiry of the testing period. Materials and Methods: We performed the tolerance test by implant of the composite material Dualcim. The implant test was made on two species of lab animals, Guinea pigs and Wistar rats in two versions: subcutaneous implant and intramuscular/perimuscular implant. Results: After a 21 days period, when the implant was in direct contact with the tissue, no change of the shape and consistency, color or surface of the implant occurred. Around the implants, the biocompatibility was kept under physiological limits. Conclusions: The product, in the structure and shape presented, could be easily placed under good conditions, both at the level of the subcutaneous tissue and at inter-muscular level. In case of both species and in all subjects, the histological exam proved a favorable development of the relationship between the implant body and the placing site.