Randomized 10-year clinical trial of self-etch 1-step in NCCLs

S Armstrong; F Qian; J Kolker; S Guzmán-Armstrong; M Hernández

doi:10.1016/j.dental.2023.08.020

Purpose To evaluate a single component self-etching 1-step adhesive system in non-carious cervical lesions (NCCL) after 120-month clinical performance as compared to a gold standard etch-and-rinse 3-step adhesive. Methods Thirty patients had 60 non-prepared NCCLs in two premolars (n=2 per subject) randomly restored using relative field control by two experienced clinicians with either Kerr’s etch-and-rinse 3-step adhesive resin (Optibond FL) nanofil resin-based composite (Premise) (OP) or Tokuyama’s self-etching 1-step (Bond Force) suprananofill resin-based composite (Estilite Sigma Quick) (BF). The restorations were evaluated at baseline, 6, 12, 24, 36 and 120 months clinical service regarding their biologic (sensitivity, caries, tooth integrity, periodontal response, adjacent mucosa), esthetic (surface luster, surface stain, marginal stain, color match, anatomic form) and functional (retention, marginal adaptation, patient’s view) properties. The data were analyzed with McNemar’s test, Bowker's test for symmetry, and Kaplan-Meier survival analysis (alpha=0.05). Results The recall rate at 120 months was 40% (12/30), seven subjects declined the appointment, nine unable to be contacted, and two already having lost or replaced restorations. The relatively low recall rate appears to have been affected by the SARS-CoV-2 pandemic. Prior to the 120-month recall, no patients had declined to attend their recall appointment in this study. After 120 months, 40% of OP had minor deviations in marginal stain (p=0.046) and 27.7% of BF demonstrated retention loss (p=0.083). Comparisons of survival curves of overall length of clinical service indicated there was no statistically significant difference between the two restorations (p=0.353 for log-rank test and p=0.366 for Wilcoxon test). The overall survival rates for OP and BF at 120-month were 71.4% and 53.3%. Survival rates by clinicians were OP=100% and BF=57.1% for clinician 1 (p=0.079) and OP=50% and BF=50% for clinician 2. Conclusion No overall difference in survival was observed between OP and BF; however, the appears to be a clinician affect with one clinician having a 50% survival rate for both groups while the other clinician had 100% survival with OP and BF failures occurring only at the 120-month recall.

Randomized 10-year clinical trial of self-etch 1-step in NCCLs

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