de Oliveira Francisca Jennifer Duarte, de Sá Barbosa Bárbara Faria, de Bessa Mariana Silva, de Boa Patrick Wesley Marques, de Sousa Santos Kaiza, da Silva Júnior Arnóbio Antônio, Borges Boniek Castillo Dutra
Department of Dentistry, Universidade Federal do Rio Grande do Norte (UFRN), Senador Salgado Filho Avenue, 1787, Lagoa Nova, Natal, RN, Brazil.
Department of Pharmacy, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.
Clin Oral Investig. 2025 May 23;29(6):308. doi: 10.1007/s00784-025-06386-2.
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.
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).
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).
The novel 1% ibuprofen nanostructured topical gel was ineffective in reducing BS and did not affect tooth color change.
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.
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本研究旨在评估1%布洛芬纳米结构外用凝胶在控制诊室牙齿美白敏感（BS）方面的疗效及其对牙齿颜色变化的影响。
对40名参与者进行了一项随机、对照、三盲、半口临床试验。纳米结构布洛芬凝胶（I）和安慰剂（P）在每次半口牙齿美白（35%过氧化氢；1×50分钟；分两次，间隔一周）前后随机涂抹10分钟。使用视觉模拟量表（VAS）评估美白敏感性（BS），计算绝对风险、相对风险和BS强度。使用维他经典比色板（ΔSGU）主观测量颜色变化，使用易美分光光度计客观测量（ΔE、ΔE00、ΔWID）。采用配对t检验、威尔科克森检验和麦克尼马尔检验进行统计分析（p<0.05）。
I组和P组在BS的绝对风险（80%对77%）或1小时（0.6对0.8）、24小时（0.2对0.1）或48小时（0.0对0.0）的BS强度方面未发现统计学显著差异。BS强度为低到中度。两组间颜色变化在统计学上也相似：ΔE（12.81±4.68对12.65±5.32）、ΔE00（8.50±3.71对8.52±4.03）、ΔWID（8.06±7.55对8.34±6.90）和ΔSGU（两者均为7.42±2.94）。
新型1%布洛芬纳米结构外用凝胶在降低BS方面无效，且不影响牙齿颜色变化。
1%布洛芬纳米结构外用凝胶不干扰牙齿颜色变化，但在降低诊室牙齿美白敏感的风险或强度方面无效。尽管该制剂在先前的动物研究中取得了阳性结果，但这些结果在人体中未得到重复，这突出了即使在动物模型中成功，也需要进行临床试验来确认任何管理美白敏感方法的疗效。
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