http://orcid.org/0000-0002-8821-1624
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Abstract
Aim: Compare clinical performance and success/retention rates of two multi-mode (MM) adhesives, applied in self-etch (SE) or etch-and-rinse (ER) modes, with SE-all-in-one adhesive (SE/SE with enamel etching) in NCCL restorations at one-year follow-up.
Material and methods: Prospective, double-blind RCT approved by the University Fernando Pessoa and the National-Clinical-Research-Ethics Committees (CEIC-20150305), ClinicalTrials.gov registered (NCT02698371), in 38 participants with 210 restorations (AdmiraFusion®) randomly allocated to six groups (Adhesives_Adhesion mode), each with 35 restorations: G1-Control Futurabond®DC_SE; G2-Control Futurabond®DC_SE with enamel etching; G3-Futurabond®U_ER; G4-Futurabond®U_SE; G5-Adhese®Universal_ER; G6-Adhese®Universal_SE. Restorations evaluated at baseline and one-year by three calibrated examiners (ICC ≥0.952) using FDI criteria and statistical analysis with nonparametric tests (alpha = 0.05).
Results: At one-year recall 36 participants, 199 restorations were available for examination; five (2.5%) restorations (G1 n = 2; G2, G3, G4 n = 1) were lost due to retention (p > .05); G1 showed less satisfying marginal adaptation (p < .05) than G2 and MM adhesives groups, particularly G6. Overall success rates (p > .05) were: 93.9% (G1), 97.0% (G2; G3; G4) and 100.0% (G5; G6).
Conclusions: MM adhesives (Futurabond®U and Adhese®Universal) showed similar and acceptable performance/success rates but also better clinical outputs than the SE-all-in-one adhesive (Futurabond®DC), particularly in SE mode. Success and retention rates were similar and not dependent on materials or adhesion modes.
Acknowledgements
The authors are grateful to Fundação Fernando Pessoa, Porto, Portugal, and to all the participants for their cooperation.
Ethical approval
All study procedures involving the participants were performed in accordance with ethical standards and with the 1964 Helsinki Declaration and subsequent amendments thereto. This study was formally approved, monitored and reviewed by the University Fernando Pessoa Ethics Committee, Infarmed (Portuguese National Authority of Medicines and Health Products) and the Portuguese National Ethics Committee for Clinical Research (CEIC).
Informed consent
After explaining to all individual the purposes, risks, benefits and all information about their participation in this RCT, written informed consent was obtained from all participants enrolled into the study.
Disclosure statement
The authors received no financial support and declare no conflicts of interest. All authors have read and approved the final version of this manuscript.