Objectives: The purpose of this randomized controlled clinical trial was to test the hypothesis that a two-step self-etch approach is equally effective to restore cervical class-V lesions as a self-etch approach with beforehand selective etching of enamel using phosphoric acid.
Methods: Twenty-nine patients received two or four restorations randomly following two experimental protocols ('paired-tooth' study design): (1) A 'mild' self-etch adhesive (Clearfil SE, Kuraray) was applied following a self-etch approach on both enamel and dentin (C-SE non-etch); (2) Similar application of Clearfil SE, but including beforehand selective acid-etching of the enamel cavity margins with 40% phosphoric acid (C-SE etch). Clearfil AP-X (Kuraray) was used as restorative composite for all 100 restorations. The clinical effectiveness was recorded in terms of retention, marginal integrity and clinical micro-leakage after 2 years of clinical service.
Results: No restoration losses were recorded. Clinical micro-leakage was slight and only rarely observed. No significant differences were found between both groups for the diverse parameters evaluated except for the number of small incisal marginal defects, which was significantly higher in the C-SE non-etch group (McNemar: p = 0.0391).
Significance: The clinical effectiveness of the mild two-step self-etch adhesive Clearfil SE was excellent after 2 years of clinical service. Although in general no difference in clinical performance was recorded when Clearfil SE was applied following either of the experimental protocols, more marginal defects at the enamel side were noticed when enamel was not beforehand etched with phosphoric acid. However, these defects were small and of clinically negligible relevance.