A Randomized Controlled Trial in Class II: 1-year Results

Objectives: The aim of the study was to test two bonding systems with the same composite in class II cavities with margins in dentin. Methods: A computer-generated random numbers table and a concealment in sealed envelopes were used and 41 patients,17 males and 24 females, between 25 and 55, respecting the inclusion-exclusion criteria, were selected: 35 patients with 2 class II and 70 teeth, 6 patients with 4 class II and 24 teeth, for a total of 94 teeth. The materials selected were the test adhesive (Adper Scotchbond SE), the control adhesive (Adper Single Bond Plus) and the composite (Supreme XT) (3M-Espe). The procedures were done according with manufacturer's instructions with the same clinical protocol by two expert operators. The restorations were evaluated by two independent examiners with an intra, inter- agreement >80%, with a loop (4.5) according with USPHS modified criteria at baseline, 6, 12 months. A statistical analysis with Mann-Whitney non parametric test was performed (p<0.05). Results: After 12 months 40 patients and 92 restorations were assessed: between the teeth treated with the control adhesive, 3 elements showed intermittent low sensitivity to cold stimulus, 1 tooth showed sensitivity to chewing. The other parameters were evaluated Alpha for all the restorations in both groups. There was not a significant difference (p>0.05) between control and experimental treatment. Conclusions: Within the limits of this RCT, the clinical significance seems to orient the practitioner to use a SE for a better control of the post-operative complications like sensitivity and pain to chewing, even if there is not a statistical difference between the two groups.