Six and 12 months' evaluation of a self-etching primer versus two-stage etch and prime for orthodontic bonding: A randomized clinical trial

The aim of the study was to compare the mean clinical chair-side time required for bracket bonding and the mean bond failure rate at 6 and 12 months of stainless steel brackets with a micro-etched base bonded with a light-cured composite using a self-etching primer (SEP) or a two-stage etch and prime system. Fifty-one subjects who required upper and/or lower pre-adjusted edgewise fixed appliances were recruited in a single centre randomized clinical trial. The trial was a single-blind design, involving a within-patient comparison of the two bonding systems with each patient randomly allocated the two bonding systems for each side of the mouth (all teeth except molars). The two bonding techniques used were standardized throughout the trial and all bracket bonding was performed by a single operator. Bonding time was recorded using a digital timer. The bond failure rate of a strictly paired sample was recorded at 6 and 12 months for each patient. The mean bracket bonding time per patient with the SEP was significantly less than that with the two-stage bonding system (mean difference 24.9 seconds; 95 per cent confidence interval 22.1-27.7 seconds; paired t-test P < 0.001). The overall bond failure rates at 6 and 12 months with the SEP were 0.8 and 1.6 per cent, respectively, and for the two-stage etch and prime 1.1 and 3.1 per cent, respectively. At 6 months, the mean bond failure rate per patient with the SEP was 0.81 per cent and with the two-stage bonding system 0.96 per cent (P = 0.87; Wilcoxon signed rank test). At 12 months, the mean bond failure rate with the SEP per patient was 1.54 per cent and with the two-stage bonding system 2.78 per cent (P = 0.33; Wilcoxon signed rank test). The mean bracket bonding time with the SEP per patient was significantly shorter than that of the two-stage bonding system (P < 0.001). The difference between the overall bond failure rate and the mean bond failure rate per patient for the two bonding systems was not statistically nor clinically significant at 6 and 12 months (P = 1.00 and P = 0.125, respectively; McNemar's test).