A New Dual-cure Universal Simplified Adhesive: 18-month Randomized Multicenter Clinical Trial.

Abstract

Non-carious cervical lesion restorations using a dual-cure universal adhesive in self-etch and etch-and-rinse mode showed satisfactory clinical performance after 18 months. Objectives: The objective of this multicenter, double-blind, split-mouth randomized clinical trial was to evaluate the clinical performance of a new dual-cure universal adhesive system (Futurabond U, Voco GmBH) when applied using different strategies over a period of 18 months.Methods and Materials: Fifty patients participated in this study. Two hundred non-carious cervical lesions were restored using the adhesive Futurabond U according to four adhesive strategies (n=50 per group): only self-etch (SEE), selective enamel etching + self-etch (SET), etch-and-rinse with dry dentin (ERDry), and etch-and-rinse with wet dentin (ERWet). After the adhesive application, cavities were restored using Admira Fusion composite resin. These restorations were evaluated according to FDI World Dental Federation criteria for the following characteristics: retention/fracture, marginal adaptation, marginal staining, postoperative sensitivity, and caries recurrence.Results: After 18 months, only four patients (12 months: one patient, n=4 restorations; and 18 months: three patients, n=12 restorations) were not evaluated. Fourteen restorations were lost after 18 months of clinical evaluation (four for SEE, three for SET, three for ERDry, and four for ERWet). The retention rates for 18 months (95% confidence interval) were 92% (81%-97%) for SEE, 94% (83%-97%) for SET, 94% (83%-97%) for ERDry, and 92% (81%-97%) for ERWet (p>0.05). Thirty-eight restorations were considered to have minor discrepancies in marginal adaptation at the 18-month recall (13 for SEE, 13 for SET, six for ERDry, and six for ERWet; p>0.05). Fourteen restorations were detected as a minor marginal discoloration at the 18-month recall (six for SEE, six for SET, one for ERDry, and one for ERWet; p>0.05). However, all were considered clinically acceptable. No restorations showed postoperative sensitivity or caries recurrence at the time.Conclusion: The clinical performance of the Futurabond U did not depend on the bonding strategy used, and it was considered reliable after 18 months of clinical evaluation, although more marginal discrepancy was observed in the self-etch group.