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

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.

Two-year clinical evaluation of proanthocyanidins added to a two-step etch-and-rinse adhesive.

OBJECTIVE: To compare the clinical behavior of Proanthocyanidins (PA)-free and PA-containing two-step etch-and-rinse adhesive used underneath resin composite restorations in non-carious cervical lesions (NCCLs) over a 6- (6 M) and 24-month (24 M) period. METHODS: 135 restorations were randomly placed in 45 subjects. The NCCLs were conditioned (37% phosphoric acid for 15 s) and distributed into 3 groups: Control (EX0) - ExciTE F (Ivoclar Vivadent) adhesive applied following the manufacturer's recommendations; EX2 and EX5 - 2 wt% and 5 wt% of PA were added to ExciTE F, respectively, and applied as in EX0. Resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline, 6 M and 24 M, using FDI and USPHS criteria. Statistical analyses were performed using Friedman and Wilcoxon tests (α = 0.05). RESULTS: The retention rates were 98% (95% confidence interval 88-99%) for EX0, 92% (80-97%) for EX2; and 85% (72-93%) for EX5 at 6 M. A significant difference was found only for EX5 at 6 M when compared with the respective baseline findings (p = 0.03) and when compared with EX0 and EX2 (p = 0.001) at 6 M. After 24 M, the retention rates were 98% (88-99%) for EX0, 73% (59-84%) for EX2, and 71% (56-82%) for EX5. Only EX0 did not result in significant difference in retention rate at 24 M when compared with baseline but showed a significant higher retention rate when compared with those of EX2 and EX5 (p = 0.001). CONCLUSION: Adding proanthocyanidins to the adhesive solution jeopardized the retention of composite resins restorations in non-carious cervical lesions after 24 months. CLINICAL RELEVANCE: In spite of being user-friendlier than when used separately, the incorporation of proanthocyanidins into the adhesive solution impairs the longevity of composite restorations.