Thirteen-year randomized controlled clinical trial of a two-step self-etch adhesive in non-carious cervical lesions

Objective. The objective of this randomized controlled clinical trial was to evaluate the 13-year clinical performance of a mild two-step self-etch adhesive in non-carious cervical lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins. Methods. A total of 100 non-carious cervical lesions in 29 patients were restored with Clearfil AP-X (Kuraray Noritake). The composite restorations were bonded following two different approaches: (1) application of Clearfil SE Bond (Kuraray Noritake) following a self-etch approach (CSE-NE); (2) selective phosphoric acid-etching of enamel cavity margins before application of Clearfil SE Bond (CSE-E). The restorations were evaluated after 6 months, 1, 2, 3, 5, 8 and 13 years of clinical service regarding retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity. Results. The patient recall rate at 13 years was 62%. Six restorations, 4 of the CSE-NE group and 2 of the CSE-E group, were clinically unacceptable due to loss of retention (1 CSE-NE, 1 CSE-E), a severe marginal defect (2 CSE-NE, 1 CSE-E) and caries occurrence in combination with a severe marginal defect (1 CSE-NE) leading to a clinical success rate of 86% (CSE-NE) and 93% (CSE-E). Ageing of the restorations was characterized by a further increase in the percentage of restorations with a clinically acceptable small marginal defect (CSE-NE: 87%; CSE-E: 83%) and/or superficial marginal discoloration (CSE-NE: 53%; CSE-E: 56%). The presence of small marginal defects (CSE-NE: 86%; CSE-E: 68%) and superficial marginal discoloration (CSE-NE: 41%; CSE-E: 20%) at the incisal enamel side was more frequently noticed in the CSE-NE group than in the CSE-E group. The difference, however, was not statistically significant (McNemar, p >0.05). Signcance. After 13 years, the clinical effectiveness of Clearfil SE Bond in non-carious ClassV lesions 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. (C) 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.