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

Abstract

Clinical Relevance 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. SUMMARY 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.

A new preheating thermoviscous composite for restoration of non-carious cervical lesions: a 6-month randomized clinical trial

“…Elkaffas et al [27] used the United States Public Health Service criteria, and the authors of the present study used a more sensitive and standardized criteria, known as FDI criteria [44]. This fact justify the report of these defects has been increasingly observed when FDI was used, as observed in previous studies [39,42,45]. However, it is noteworthy that most of these defects are clinically acceptable and easily solved with a repolishing of the restorations [46].…”

“…Although only short-term clinical data has been reported, the observed success rate should be attributed to the composition of universal adhesive used. Several clinical studies have shown that universal adhesives with ultra-mild/mild pH and containing the acidic functional monomer 10-MDP (10-methacryloyloxydecyl dihydrogen phosphate), such as Futurabond U, yield better clinical results than universal adhesives with a high pH and without 10-MDP [39][40][41][42]. It is noteworthy that all restorations were completed with universal adhesive applied in the self-etch mode associated with the selective enamel etching, because this strategy has shown better clinical performance that only self-etching [30,43].…”

Efficacy of adhesive strategies for restorative dentistry: A systematic review and network meta-analysis of double-blind randomized controlled trials over 12 months of follow-up

“…The treatment protocols of adhesive-involved restorations were classified as etch-and-rinse (Nr = 1110; number of NCCLs = 964), selective enamel-etching protocols (Nr = 404; number of NCCLs = 358), and self-etch protocols without selective enamel-etching (Nr = 892; number of NCCLs = 746). Most of the trials were of double-blind design, as the clinicians who evaluated the outcomes during follow-ups were blinded, and were not the clinicians who performed the restorations [21,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. Due to the study design of the 16 RCTs, all trials were under low risk of bias.…”

“…For instance, a previous meta-analysis suggested that shear bond strength of universal adhesives was improved with prior acid etching of enamel [16]. Since most of the above-mentioned studies were either conducted in relatively short follow-ups, or were of in vitro study designs, for which clinically relevant conclusion cannot be made; moreover, various pathologic conditions of substrates, such as carious or sclerotic dentin, or enamel, may result in varied clinical outcomes [2], t the purpose of this study was to determine the efficacy (≥ 12 months) of three adhesive strategies for restorations using universal adhesives: etch-andrinse, selective enamel-etching, and self-etching without selective etching, through published results of several large-scale randomized controlled trials (RCTs) [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. Accordingly, we performed a network meta-analysis on multi-arm [38,39] outcomes from both doubleblind and single-blind RCTs [21,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] to compare esthetic, functional, and biological outcomes in terms of World Dental Federation (FDI) criteria and the United States Public Health Service (USPHS) criteria of the three adhesive strategies.…”

Eighteen-month clinical evaluation of a new universal adhesive applied in the “no-waiting” technique: a randomized clinical trial

“…Two experienced and calibrated dentists, not involved with the restoration procedures and therefore blinded to the group assignment, evaluated all the restorations once and independently using the World Dental Federation (FDI) [ 33 ] and classical US Public Health Service (USPHS) criteria [ 34 , 35 ] at the baseline and after 6 and 18 months of clinical service. In a case of disagreement between the examiners, a consensus was reached by re-examination and discussion before the patient was dismissed [ 13 , 36 , 37 ]. Only clinically relevant measures for evaluating the performance of the adhesives were used and scored (Tables 2 and 3 ).…”