Performance of 2 packable composites at 12 months

Objective: The purpose of this randomized, double-blind, clinical trial was to compare the marginal seal of 2 packable resin composite materials in moderate to large lesions on molars. Method and Materials: Fifty participants in need of a moderate to large Class 2 or complex Class 1 molar restoration were randomly distributed into 4 groups, to receive either Alert (Jeneric/Pentron) or SureFil (Dentsply/Caulk) resin composite with or without a surface sealer. Each participant received one restoration. With the exception that study protocol limited increments to no more than 4 mm, teeth were restored according to the manufacturers' instructions, and surface sealer was applied after finishing in the designated groups. Use of Alert includes routine placement of a flowable composite liner. Clinical performance of the restorations was evaluated in 8 categories at baseline, 6 months, and 12 months. The 2 materials were compared to determine if a difference in marginal seal existed between groups. The number of restorations exhibiting marginal staining was compared using Fischer's exact test at a significance level of 5%. Results: Six participants did not present for the 12-month recall. At 12 months, 19 (90.5%) Alert restorations and 15 (68.2%) SureFil restorations did not exhibit marginal staining. There was no statistically significant difference between the 2 restorative materials for marginal staining. Overall, 3 restorations were rated as failures. Conclusion: At 12 months, materials placed with a flowable liner were not associated with a significant reduction in marginal staining.