Toxicity testing of sealants: a tissue implant study.

The toxicity of pit and fisure sealants implanted into the subcutaneous tissues of guinea pigs was tested using the protocol for toxicity testing derived from the ADA/ANSI Document No. 41, 1982. The materials tested were Delton autopolymerized and photopolymerized, and Concise White autopolymerized and photopolymerized. After two weeks, reactive fibrosis and mild to moderately severe foreign body reactions were noted. After 12 weeks, only thin fibrous walls infiltrated occasionally by small numbers of chronic inflammatory cells were observed. The results of this investigation appear to indicate that following subcutaneous implantation of a pit and fissure sealant, a foreign body reaction will most likely take place during the first two weeks, but will be resolved by 12 weeks. Furthermore, than an initial reactive fibrosis will give way to a thin fibrosis wall by 12 weeks, and the initial inflammatory response will subside. It can also be stated that in this study, Delton and Concise White sealant materials produced similar tissue reactions, and that there were few differences between materials which were autopolymerized or photopolymerized.