Eight-year clinical evaluation of a 2-step self-etch adhesive with and without selective enamel etching.

OBJECTIVES The objective of this randomized controlled clinical trial was to evaluate the 8-year clinical performance of a mild 2-step self-etch adhesive in non-carious Class-V lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins. METHODS A total of 100 non-carious Class-V lesions in 29 patients were restored with Clearfil AP-X (Kuraray). The composite restorations were bonded following two different approaches: (1) application of Clearfil SE (Kuraray) following a self-etch approach (control group; C-SE non-etch), (2) selective phosphoric acid-etching of the enamel cavity margins before application of Clearfil SE (experimental group; C-SE etch). The restorations were evaluated after 6 months, 1, 2, 3, 5 and 8 years of clinical service regarding their retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity. RESULTS The recall rate at 8 years was 76%. Only two restorations, one of the C-SE non-etch group and one of the C-SE etch group, were clinically unacceptable due to loss of retention leading to a retention rate and a clinical success rate of 97% in both groups. Aging of the restorations was characterized by an increase in the percentage of restorations with a small but clinically acceptable marginal defect (C-SE non-etch: 92%; C-SE etch: 84%) and/or a superficial marginal discoloration (C-SE non-etch: 44%; C-SE etch: 28%). At the enamel side, the presence of small marginal defects (C-SE non-etch: 86%; C-SE etch: 65%) and superficial marginal discoloration (C-SE non-etch: 11%; C-SE etch%) was more frequently noticed in the control group than in the experimental group. The difference, however, was only statistically significant for the presence of superficial marginal discoloration (McNemar, p=0.01). SIGNIFICANCE After 8 years of clinical functioning, the clinical effectiveness of Clearfil SE remained excellent, with selective acid-etching of the enamel cavity margins only having some minor positive effect on marginal integrity and absence of marginal discoloration at enamel.