Clinical, double blind, randomized controlled trial of experimental adhesive protocols in caries-affected dentin
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To evaluate the clinical performance of posterior resin composite restorations regarding experimental and regular adhesive protocols in caries affected-dentin (CAD).
Material and methods
A total of 92 class I and class II cavities with carious lesions were selected and randomly assigned to the following groups: (1) bioactive glass-ceramic powder/two-step etch and rinse system, (2) control/two-step etch and rinse system, (3) bioactive glass-ceramic powder/two-step self-etching system, and (4) control/two-step self-etching system. Two operators carried out the adhesive protocols and restored the cavities with a nano-hybrid resin composite. Participants were followed up at 1 week and 6, 12, and 18 months for clinical evaluation performed by two blinded examiners and calibrated according to FDI criteria. Data were analyzed using Kruskal-Wallis and Dunn tests with a confidence of 95%.
The clinical performance of resin composite restoration was not affected by the experimental use of an adhesive protocol including a bioactive glass-ceramic powder for 18 months post-procedure. However, there was a significant difference between group 2 and group 4 (p < 0.05) for marginal adaptation (18 months). Group 2 was significantly different from group 3 (p < 0.05) for fracture of material/retention (18 months) and marginal adaptation (1 week); group 2 showed a better performance.
Adhesive protocols can alter the clinical performance of posterior restorations in terms of marginal adaptation and the fracture of material/retention in CAD. Clinical significance: Adhesive protocols may influence the success of resin composite restorations in CAD; this is important because failure can lead to caries, re-incidence, and/or clinical re-work.
KeywordsBioactive glasses Caries-affected dentin Randomized controlled trial
This study was funded by the São Paulo Research Foundation - FAPESP (grant number 2010/12032-6) and Center for Research, Teaching and Innovation in Glass (CeRTEV)/CEPID grant number 2013/07793-6.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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