Clin Oral Investig. 2025 May 23;29(6):308. doi: 10.1007/s00784-025-06386-2.
ABSTRACT
OBJECTIVES: This study aimed to evaluate the efficacy of a 1% ibuprofen nanostructured topical gel in controlling in-office bleaching sensitivity (BS) and its impact on tooth color change.
METHODS: A randomized, controlled, triple-blind, split-mouth clinical trial was conducted with 40 participants. The nanostructured ibuprofen gel (I) and placebo (P) were applied for 10 min before and after bleaching (35% hydrogen peroxide; 1 × 50 min; two sessions, one week apart) on each hemi-arch, randomly assigned. Bleaching sensitivity (BS) was assessed using the Visual Analog Scale (VAS), calculating absolute risk, relative risk, and BS intensity. The color change was measured subjectively with the Vitapan Classical® shade guide (ΔSGU) and objectively with the EasyShade® spectrophotometer (ΔE, ΔE00, ΔWID). Statistical analyses were performed using the paired t-test, Wilcoxon, and McNemar tests (p < 0.05).
RESULTS: No statistically significant differences were found between I and P for absolute risk of BS (80% vs. 77%) or BS intensity at 1 h (0.6 vs. 0.8), 24 h (0.2 vs. 0.1), or 48 h (0.0 vs. 0.0). BS intensity was low to moderate. The color change was also statistically similar between groups: ΔE (12.81 ± 4.68 vs. 12.65 ± 5.32), ΔE00 (8.50 ± 3.71 vs. 8.52 ± 4.03), ΔWID (8.06 ± 7.55 vs. 8.34 ± 6.90), and ΔSGU (7.42 ± 2.94 for both).
CONCLUSION: The novel 1% ibuprofen nanostructured topical gel was ineffective in reducing BS and did not affect tooth color change.
CLINICAL RELEVANCE: The 1% ibuprofen nanostructured topical gel did not interfere with tooth color change but was ineffective in reducing the risk or intensity of in-office bleaching sensitivity. Although the formulation yielded positive results in a previous animal study, these outcomes were not replicated in humans, underscoring the need for clinical trials to confirm the efficacy of any approach for managing bleaching sensitivity, even if successful in animal models.
CLINICAL TRIAL REGISTRATION NUMBER: RBR-4ng46xj.
PMID:40407907 | DOI:10.1007/s00784-025-06386-2
