Five-year Clinical Effectiveness of a Two-step Self-etching Adhesive

Purpose: The purpose of this prospective randomized controlled clinical study was to evaluate the clinical performance of a "mild" two-step self-etching adhesive, Clearfil SE, in Class V restorations after 5 years of clinical functioning. Materials and Methods: Twenty-nine patients received two or four restorations following two randomly assigned experimental protocols: (1) a mild self-etching adhesive (Clearfil SE, Kuraray) was applied following manufacturer's instructions on both enamel and dentin (C-SE non-etch); (2) similar application of Clearfil SE, but including prior selective acid-etching of the enamel cavity margins with 40% phosphoric acid (C-SE etch). Clearfil AP-X (Kuraray) was used as the restorative composite for all 100 restorations. The clinical effectiveness was recorded in terms of retention, marginal integrity, marginal discoloration, caries recurrence, postoperative sensitivity, and preservation of tooth vitality after 5 years of clinical service. The hypothesis tested was that selective acid etching of enamel with phosphoric acid improved retention, marginal integrity, and clinical microleakage of Class V restorations. Results: Only one restoration of the C-SE non-etch group was lost at the 5-year recall. All other restorations were clinically acceptable. Marginal integrity deteriorated with time in both groups. The number of restorations with defect-free margins was significantly lower in the C-SE non-etch group (p = 0.0043). This latter group presented significantly more small incisal marginal defects on the enamel side (p = 0.0169). Superficial marginal discoloration increased in both groups, but was more pronounced in the C-SE non-etch group and was related to the higher frequency of small incisal marginal defects. Conclusion: The clinical effectiveness of the two-step self-etching adhesive Clearfil SE remained excellent after 5 years of clinical service. Additional etching of the enamel cavity margins resulted in an improved marginal adaptation on the enamel side; however, this was not critical for the overall clinical performance of the restorations. Keywords: adhesives, clinical trial, cervical lesions, composite restoration.