title: Thirteen-year randomized controlled clinical trial of a two-step self-etch adhesive in non-carious cervical lesions.
abstract: 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).
  
  
  CONCLUSIONS
  After 13 years, the clinical effectiveness of Clearfil SE Bond in non-carious Class-V 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.
authors: KU Leuven-BIOMAT, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium. Electronic address: marleen.peumans@med.kuleuven.be.
authors: M
authors: M
authors: Peumans
authors: KU Leuven-BIOMAT, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.
authors: J
authors: J
authors: De Munck
authors: KU Leuven-BIOMAT, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.
authors: K
authors: K
authors: Van Landuyt
authors: KU Leuven-BIOMAT, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.
authors: B
authors: B
authors: Van Meerbeek
mesh_terms: D000134:Acid Etching, Dental / Q000379:methods*; D018772:Dental Marginal Adaptation; D003793:Dental Restoration, Permanent / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008689:Methacrylates / Q000737:chemistry*; D008875:Middle Aged; D019279:Resin Cements / Q000737:chemistry*; D019237:Tooth Cervix / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: C112828:Clearfil AP-X; C438313:Clearfil SE Bond; D008689:Methacrylates; D019279:Resin Cements
keywords: Adhesive; Composite restoration; Non-carious cervical lesion; Randomized clinical trial; Self-etch