Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years

Abstract

The effectiveness of a universal adhesive applied in different application modes for the preparation of Class V composite restorations was evaluated both clinically and by quantitative marginal analysis (QMA). In each of the 22 patients, four non-carious cervical lesions (NCCL) were restored with Filtek™ Supreme XTE (3M). The adhesive Scotchbond™ Universal (SBU, 3M) was applied in self-etch (SE), selective-enamel-etch (SEE) or etch-and-rinse (ER) modes. The etch-and-rinse adhesive OptiBond™ FL (OFL, Kerr) served as a control. The restorations were clinically evaluated (FDI criteria) after 14 days (BL), 6, 12, 24, and 36 months. Additionally, QMA was conducted on all restorations of 11 randomly selected patients. The FDI criteria and marginal gap were statistically compared between the groups at each recall as well as for the time periods between recalls. The cumulative failure rate was non-significantly higher in the OFL group when compared to all of the SBU groups. Marginal adaptation in the OFL and SBU-SE/ER groups was significantly decreased (BL-36 m, p: 0.004) in comparison to the SBU-SEE group (BL-36 m, p: 0.063). More marginal gaps were found in the OFL group than in the SBU-SEE (BL to 36 m, p: 0.063–0.003) and SBU-ER (24/36 m, p: 0.066/0.005) groups as well as in the SBU-SE group when compared to the SBU-SEE (12–36 m, pi ≤ 0.016) and SBU-ER (24/36 m, p: 0.055/0.001) groups. SBU-SEE performed most effectively. The clinical evaluation and QMA corresponded, yet QMA detected group differences earliest after 6 months and is thus a valuable extension to clinical evaluations.

Keywords

• universal adhesive
• clinical trial
• FDI criteria
• quantitative marginal analysis
• marginal gap