Scholarlink

Objectives <p>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.</p> Methods <p>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&#xa0;min before and after bleaching (35% hydrogen peroxide; 1 × 50&#xa0;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<sup>®</sup> shade guide (ΔSGU) and objectively with the EasyShade<sup>®</sup> spectrophotometer (ΔE, ΔE00, ΔWID). Statistical analyses were performed using the paired t-test, Wilcoxon, and McNemar tests (<i>p</i> &lt; 0.05).</p> Results <p>No statistically significant differences were found between I and P for absolute risk of BS (80% vs. 77%) or BS intensity at 1&#xa0;h (0.6 vs. 0.8), 24&#xa0;h (0.2 vs. 0.1), or 48&#xa0;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).</p> Conclusion <p>The novel 1% ibuprofen nanostructured topical gel was ineffective in reducing BS and did not affect tooth color change.</p> Clinical relevance <p>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.</p> Clinical trial registration number <p>RBR-4ng46xj.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Efficacy of a 1% ibuprofen nanostructured topical gel in reducing in-office bleaching sensitivity following 35% hydrogen peroxide application: a randomized, controlled, triple-blind, split-mouth clinical trial

  • 期刊论文

  • 发表日期：

    2025年5月23日

查看全文
  • Francisca Jennifer Duarte de Oliveira,
  • Bárbara Faria de Sá Barbosa,
  • Mariana Silva de Bessa,
  • Patrick Wesley Marques de Boa,
  • Kaiza de Sousa Santos,
  • Arnóbio Antônio da Silva Júnior,
  • Boniek Castillo Dutra Borges

摘要

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.