Thirteen-year Clinical Evaluation of a Two-step Self-etch Adhesive

Method: A total of 100 non-carious Class-V lesions in 29 patients were restored with Clearfil AP-X (Kuraray Noritake) following two different approaches: 1. application of Clearfil SE Bond (Kuraray) following a solely self-etch approach (C-SE_NE); 2. selective phosphoric acid-etching of the enamel cavity margins before application of Clearfil SE Bond (C-SE_E). The restorations were evaluated after 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.

Result: The patient recall rate at 13 years was 59%. Five restorations, 3 of the C-SE_NE group and 2 of the C-SE_E group, were clinically unacceptable due to loss of retention (1 C-SE_NE or 4%, 1 C-SE_E or 4%) or a severe marginal defect (2 C-SE_NE, 1 C-SE_E) leading to a  clinical succes rate of 89% (C-SE_NE) and 93% (C-SE_E). Aging of the restorations was characterized by a further increase in the percentage of restorations exhibiting a (clinically acceptable) small marginal defect (C-SE_NE: 85%; C-SE_E: 76%) and/or superficial marginal discoloration (C-SE_NE: 59%; C-SE_E: 52%). The presence of small marginal defects (C-SE_NE: 85%; C-SE_E: 65%) and superficial marginal discoloration, (C-SE_NE: 41%; C-SE_E: 21%) at the incisal enamel side was more frequently noticed in the C-SE_NE group than in the C-SE_E group. The difference, however, was not statistically significant (McNemar, p>0.05). 

Conclusion: After 13 years of clinical functioning, the clinical effectiveness of the 10-MDP-containing Clearfil SE Bond 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.