Clinical biocompatibility of an experimental dentine-enamel adhesive for composites.

Previous studies have shown that sequential application of an acidified solution of ferric oxalate, N-phenylglycine and PMDM (the reaction product of pyromellitic dianhydride and hydroxyethyl methacrylate) yields strong adhesive bonding of composite resins to both dentine and enamel. The purpose of this study was to evaluate the clinical characteristics and the biocompatibility of this system in human teeth scheduled for extraction in the course of orthodontic treatment. Controls were light-cured Scotch-bond or ZOE in contralateral teeth. Evaluation criteria, which included clinical feasibility, patient acceptability, retention, margin aesthetics and human pulp response, were met. Within the 4-241 day observation periods, there was no postoperative sensitivity, pain, loss of retention, staining or discolouration. All pulp responses (double-blind pulp analysis including all teeth) were acceptable. With mean (+/- SD) remaining dentine thickness (RDT) of 0.67 +/- 0.35 mm, all indicators of pulp inflammation (displacement, superficial response, deep response etc.) averaged between none and slight, under 1 on a 0-4 scale. Both controls gave similar results. Linear regression analysis indicated low responses at all RDTs. The experimental material is safe and effective; further unrestricted clinical evaluations in teeth to be retained are indicated.