IADR location:Goteborg, Sweden date:25-28 june 2003
Objectives: The purpose of this double-blind, split-mouth, randomized controlled clinical trial was to test the hypothesis that using a self-etch adhesive additional acid-etching of enamel is beneficial in terms of retention and marginal adaptation of Class-V restorations. Methods: 28 patients received two or four restorations randomly following two experimental protocols: (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 96 restorations. The clinical effectiveness was recorded in terms of retention (R), perfect marginal integrity (MI), absence of small incisal marginal defects (I-MI), absence of small cervical marginal defects (C-MI), absence of clinical microleakage (CM), absence of caries recurrence (CR) and absence of post-operative sensitivity (PS) after 2 years of clinical service. Results: No restoration losses were recorded. Clinical microleakage was rarely observed. Almost no differences between both groups were found for the diverse parameters evaluated except for the number of small marginal defects (mainly incisal), which was significantly higher in the C-SE non-etch group (McNemar p=0.0156).
Conclusion: 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, a tendency towards more marginal defects at the enamel side was noticed when enamel was not beforehand etched with phosphoric acid. However, these defects were small and of clinical negligible relevance.