Objectives: The purpose of this practice-based randomized controlled trial was to evaluate the effectiveness of a new one-step self-etch adhesive to restore non-carious cervical lesions following CONSORT guidelines and to test the hypothesis that this adhesive is equally effective with or without beforehand selective etching of enamel.
Methods: Twenty-eight patients each received two restorations randomly assigned to the control or the experimental group. In the control group, the adhesive (Bond Force, Tokuyama) was applied without beforehand enamel phosphoric-acid-etching, whereas the latter was applied first in the experimental group. The restorative composites used for all restorations were Estelite Flow Quick followed by Estelite Sigma (Tokuyama). The clinical effectiveness was assessed at baseline, 6 months, 1 year and 2 years in terms of retention, marginal staining, restoration staining, and post-operative sensitivity.
Results: One restoration loss occurred in the control group before the 6-month recall. At the two-year recall, only 2 secondary endpoints showed significant differences between groups: marginal staining at the enamel occurred more often in the control group (29% vs. 5%) (hierarchical linear regression: p=0.011) and 'minor marginal defects' were significantly more frequent in the control group (29% vs. 0%) (hierarchical linear regression: p=0.009).
Significance: Although in a practice setting, the effectiveness of this new adhesive was very good after 2 years of clinical service. More minor defects and restoration staining at the enamel margin were noticed when enamel had not been selectively acid-etched. Selective enamel acid-etching might enhance the adhesive properties of this new one-step self-etch adhesive.
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