| Resumo: | Statement of problem. Gingival irritation is a common side effect of at-home bleaching, but how the design of the bleaching tray affects its occurrence is unclear. Purpose. The purpose of this randomized clinical trial was to determine whether a direct relationship is present between the design of bleaching trays and the risk of gingival irritation during at-home bleaching treatments. Material and methods. This clinical trial was registered at ClinicalTrials.gov. (NCT06371664). Seventy-two participants were randomly assigned to 2 experimental groups: extended bleaching tray (3 mm) and nonextended bleaching tray (1 mm). Over a period of 3 weeks, participants underwent a nightguard dental bleaching treatment (6 to 8 hours) using 16% carbamide peroxide gel. Gingival irritation was evaluated subjectively by participants daily and objectively by clinicians at each visit. Tooth sensitivity was recorded daily using a 5-point numerical scale. Tooth color measurements were also made with a dental spectrophotometer. The risk of gingival irritation and the risk and intensity of tooth sensitivity were analyzed with the Pearson chi squared test and Fisher exact test. The color analysis was conducted with the Student t test (α=.05). Results. Subjectively, the risk of gingival irritation was 66.7% in the extended group and 47.2% in the nonextended group, showing no statistically significant difference (P>.05). However, objectively, the risk of gingival irritation was significantly higher in the extended group (88.9%) compared with the nonextended group (63.9%) (P=.01(95% CI 1.06 to 1.83). Tooth sensitivity intensity was significantly higher in the extended tray group (P<.001), although the design did not significantly influence the risk of tooth sensitivity (P>.05). No significant differences were found between groups regarding color change (P>.05). Conclusions. The use of an extended bleaching tray design increases the risk of gingival irritation and the intensity of tooth sensitivity. Therefore, the nonextended tray is recommended to minimize adverse reactions. (J Prosthet Dent 2025;133:1277-1283)
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