This Phase II proposal is to develop a non-toxic pulpotomy agent, pH-adjusted glutaraldehyde (pH-GA). Formocresol, the drug most commonly used, is toxic to the treated tissue, induces antigen formation and subsequent chronic inflammation, is rapidly distributed systemically, and has mutagenic potential. Phase I compared bifunctional protein crosslinking reagents, dimethylsuberimidate (DMS) and pH-adjusted glutaraldehyde solutions, to formocresol. In vitro results indicated that pH- adjusted glutaraldehyde was the most effective alternative. Phase II will determine the best treatment regimen for pH-GA using in vitro assays. Rapidity of tissue fixation will be assayed by measuring cross-linking of fluorescent-labeled bovine serum albumin to collagen gels. Effectiveness of tissue fixation will be assessed by measurement of residual lactic dehydrogenase activity in vivo and in vitro and by ability of fixed pulp to block I131 diffusion in vivo. Depth of GA penetration of the pulp and systemic distribution of GA following pulptomy will be assessed using 14C-GA. Local and systemic toxicity will be assessed for pH- GA and each of its components using rats and dogs. Finally, clinical efficacy will be established in a pediatric dental population. These studies using deciduous teeth will provide base line data for subsequent use of pH-GA as an alternative to pulpectomy in adults.
