Purpose: Mild and intermediately strong 2-step self-etch adhesives (2SEa) have been shown to bond efficiently to dentin. In general, their bonding efficiency to enamel is inferior to that of etch & rinse adhesives (E&Ra). On the other hand, their application procedure is less elaborate, and consequently leaves less room for application mistakes. The aim of this randomized controlled trial was to evaluate the clinical performance of an intermediately strong 2SEa, as compared with that of a 3-step E&Ra after 6 years of clinical functioning.
Materials and Methods: 239 non-carious cervical lesions in 50 patients were restored with the nanohybrid composite Herculite XRV (Kerr), bonded in random order either with the 2SEa Optibond XTR (‘O-XTR’, Kerr) or the gold-standard control 3E&Ra Optibond FL (‘O-FL’, Kerr). The restorations were recalled after 1, 2 and 6 years of clinical service and examined for retention, marginal adaptation, marginal discoloration, caries occurrence, and postoperative sensitivity. Statistical analysis was performed using a logistic regression model with generalized estimating equations (2-way GEE model).
Results: The patient recall rate at 6 years was 94%. The overall clinical success rate was 81.9% and 80.9% for O-XTR and O-FL, respectively. In total, 42 restorations (21 O-XTR, 21 O-FL) failed because of retention loss, severe abfraction/abrasion/erosion, severe marginal defects and/or discoloration, and/or caries. A retention rate of 92.9% and 88.9% was recorded for O-XTR and O-FL, respectively. Progressive marginal deterioration was observed over the 6-year period. Small clinically acceptable marginal defects were recorded in about 70% of the restorations (O-XTR: 69.9%; O-FL: 74.1%). Regarding marginal discoloration, 37% of the O-XTR and 30.2% of the O-FL restorations showed superficial clinically acceptable marginal discoloration. Six O-XTR and 4 O-FL restorations exhibited caries at the restoration margin. No significant difference was observed between the two groups for any of the evaluated parameters (p > 0.05).
Conclusion: After 6 years of clinical service, Class-V restorations bonded with the 2SEa performed clinically equally well as those bonded with the 3E&Ra.
Palabras clave: randomized clinical trial, RCT, Class V, bonding, adhesion, clinical effectiveness
