Two-year clinical evaluation of a proanthocyanidins-based primer in non-carious cervical lesions: A double-blind randomized clinical trial

Lidiane Costa de Souza, Nara Sousa Rodrigues, Diana Araújo Cunha, Victor Pinheiro Feitosa, Sérgio Lima Santiago, Alessandra Reis, Alessandro D. Loguercio, Jorge Perdigão, Vicente de Paulo Aragão Saboia

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16 Scopus citations


Objectives: This double-blind randomized clinical trial evaluated the influence of pre-treatment with proanthocyanidins (PA) from grape seed extract on the clinical behavior of a simplified etch-and-rinse adhesive placed in non-carious cervical lesions (NCCLs) over 6- and 24-months. Materials and methods: A total of 135 restorations were randomly inserted in 45 subjects. The NCCLs were etched with 37 % phosphoric acid for 15 s and distributed into 3 groups: Control (PA0) - adhesive ExciTE F applied as per the manufacturer's recommendations; PA2 and PA5 groups – 2 wt% and 5 wt% PA solution, respectively, were applied for 60 s and washed for 30 s prior to application of the adhesive. The resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline, 6 months (6 m) and 24 months (24 m) using both the FDI and USPHS criteria. Statistical analyses were carried out using Friedman repeated-measures analysis of variance by rank and the Wilcoxon test (α = 0.05). Results: The retention rates were 98 % (PA0), 98 % (PA2) and 83 % (PA5) after 6 m and 93 % (PA0), 89 % (PA2) and 70 % (PA5) after 24 m. Only PA5 resulted in a significant lower retention rate at 6 m and at 24 m compared with that of baseline (p = 0.03). All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared. These differences were considered clinically acceptable under the FDI criteria. Conclusions: The application of PA as a primer did not result in clinical advantages after 24 m of clinical service, regardless of the concentration used. Clinical Relevance: It has been reported that PA, a collagen crosslinking agent, increases the durability of the dentin-resin interface. However, no effects were found clinically after 24 months.

Original languageEnglish (US)
Article number103325
JournalJournal of Dentistry
StatePublished - May 2020

Bibliographical note

Funding Information:
This investigation was supported by research grants from FUNCAP (Grant# CI3-0093-000670100/14 ) and CAPES (scholarship). The authors would like to thank the generous donations of resin composite IPS Empress Direct by Ivoclar Vivadent.

Publisher Copyright:
© 2020 Elsevier Ltd


  • Clinical study
  • Dentin-bonding agents
  • Non-carious cervical lesions
  • Proanthocyanidins


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