Evaluation of reservoirs in bleaching trays for at-home bleaching: a split-mouth single-blind randomized controlled equivalence trial

Abstract

Objectives This randomized, split-mouth, single-blinded trial assessed whether the use of reservoirs in at-home bleaching trays is equivalent to non-reservoir trays. Our choice of an equivalence trial was based on the expectation that a non-reservoir tray is sufficient to produce a color change. Secondary outcomes such as tooth sensitivity (TS) and gingival irritation (GI) were also assessed. Methodology Forty-six patients were selected with canines shade A2 or darker. In half of the patient's arch, bleaching trays were made with reservoirs and the other half, without reservoirs. At-home bleaching was performed with carbamide peroxide (CP) 10% (3 h daily; 21 days). Color change was evaluated with a digital spectrophotometer (ΔE, ΔE00, and Whiteness Index) and shade guide units (ΔSGU) at baseline, during and one-month post-bleaching. TS and GI were assessed with a numeric scale (NRS) and a visual analog scale (VAS). Results After one month, the equivalence of reservoir and non-reservoir groups were observed in all color instruments (p>0.05). Fifteen and sixteen patients presented pain (absolute risk: 33% and 35%, 95%, confidence interval (CI) 21-46% and 23-49%) in the reservoir and non-reservoir side, respectively. The odds ratio for pain was 0.8 (95%CI 0.2-3.0) and the p-value was non-significant (p=1.0). TS intensity was similar between both groups in any of the pain scales (p>0.05). No difference in the GI was observed (p>0.05). Conclusions The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching. Clinical Relevance The presence of reservoirs in a bleaching tray did not improve color change or affect tooth sensitivity and gingival irritation.

Conflict of interest statement

Conflict of interest

Eveline C Martini declares that he has no conflict of interest. Michael Favoreto declares that she has no conflict of interest. Fabiana M Coppla declares that she has no conflict of interest. Alessandro Loguercio and Alessandra Reis declares that they have no conflict of interest.

Figures

Figure 1. Flow diagram of study design phases including enrollment and allocation criteria

Figure 2. Mean differences of color change measured with different instruments between non-reservoir and reservoir groups at the different assessment times. Horizontal bars indicate two-sided 90% confidence interval (CI) of the mean difference between treatment groups. The zone between the dashed lines indicates the equivalence margin

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