Efficacy of 5% methylene blue photodynamic therapy in the treatment of potentially malignant oral disorders: a randomized, double-blind, controlled trial

Brunno Santos de Freitas Silva, Reuber Mendes Rocha, Tiago Paiva Prudente, Milena Moraes de Oliveira Lenza, Daniel Lobato Ferreira Ferraz, Eleazar Mezaiko, Francine Do Couto Lima Moreira, F. P. Yamamoto-Silva
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Abstract

Background: Potentially malignant oral disorders (PMOD) play a vital role in the secondary prevention of oral cancer, especially considering the difficulty in identifying specific risk factors. Oral leukoplakia (OL), the most common PMOD, has a variable malignant transformation rate. Photodynamic therapy (PDT) emerges as a promising alternative in treating these conditions. This approach is particularly valuable for extensive lesions or patients with contraindications to conventional treatments. Despite promising results, the choice of photosensitizer agent still lacks consensus. The aim of this study is to evaluate the efficacy of PDT with 5% methylene blue compared to 20% aminolevulinic acid (ALA) in the treatment of OL. Methods: This is a randomized, controlled, double-blind clinical trial with a non-inferiority testing approach. Patients will be allocated into two groups: leukoplakia experimental group (PDT with methylene blue) and leukoplakia control group (PDT with ALA). The analysis of results will be based on primary outcomes (clinical remission) and secondary outcomes (histological/cytological worsening, lesion appearance, symptoms, function, psychological impact, economic impact, treatment adherence, and adverse effects). Allocation will be performed in a randomized and stratified manner, ensuring equivalence between groups. Cost-effectiveness analysis will consider the direct costs of treatment from both professional and patient perspectives. Conclusions: This study aims to contribute to the establishment of an effective, safe, and accessible treatment protocol for the most prevalent PMOD, filling an important gap in the scientific literature and providing guidelines for future clinical practices.
5%亚甲基蓝光动力疗法治疗潜在恶性口腔疾病的疗效:随机、双盲、对照试验
背景:潜在恶性口腔疾病(PMOD)在口腔癌的二级预防中起着至关重要的作用,特别是考虑到很难确定具体的风险因素。口腔白斑病(OL)是最常见的恶性口腔疾病,其恶性转化率各不相同。光动力疗法(PDT)是治疗这些病症的一种很有前途的替代疗法。这种方法对于大面积病变或有传统治疗禁忌症的患者尤为重要。尽管效果良好,但对光敏剂的选择仍缺乏共识。本研究旨在评估 5%亚甲基蓝光化学疗法与 20% 氨基乙酸(ALA)光化学疗法治疗 OL 的疗效:这是一项随机、对照、双盲临床试验,采用非劣效性测试方法。患者将被分为两组:白斑病实验组(亚甲蓝 PDT)和白斑病对照组(ALA PDT)。结果分析将基于主要结果(临床缓解)和次要结果(组织学/细胞学恶化、病变外观、症状、功能、心理影响、经济影响、治疗依从性和不良反应)。将以随机和分层的方式进行分配,确保各组之间的等效性。成本效益分析将从专业人员和患者的角度考虑治疗的直接成本:本研究旨在为最常见的 PMOD 建立一个有效、安全、易行的治疗方案,填补科学文献中的一个重要空白,并为未来的临床实践提供指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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