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

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dc.contributor.authorSantos, de Freitas Silva Ben_US
dc.contributor.authorMendes, Rocha Ren_US
dc.contributor.authorPaiva, Prudente Ten_US
dc.contributor.authorMoraes, de Oliveira Lenza Men_US
dc.contributor.authorLobato, Ferreira Ferraz Den_US
dc.contributor.authorMezaiko, Een_US
dc.contributor.authordo Couto, Lima Moreira Fen_US
dc.contributor.authorYamamoto-Silva, FP.en_US
dc.date.accessioned2025-05-09T08:46:58Z
dc.date.available2025-05-09T08:46:58Z
dc.date.issued2024-09
dc.description.abstractBackground: 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.en_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazil; and University of Anápolis, Anápolis, GO, Brazilen_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazilen_US
dc.identifier.affiliationsUniversidade Federal de Goiás, Goiânia, GO, Brazilen_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazilen_US
dc.identifier.affiliationsDepartment of Oral Diagnosis, Piracicaba Dental School, State University of Campinas, Piracicaba, SP, Brazilen_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazilen_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazilen_US
dc.identifier.affiliationsDepartment of Stomatologic Sciences, School of Dentistry, Federal University of Goiás, Goiânia, GO, Brazil; and University of Anápolis, Anápolis, GO, Brazilen_US
dc.identifier.citationSantos de Freitas Silva B, Mendes Rocha R, Paiva Prudente T, Moraes de Oliveira Lenza M, Lobato Ferreira Ferraz D, Mezaiko E, do Couto Lima Moreira F, Yamamoto-Silva FP.. Efficacy of 5% methylene blue photodynamic therapy in the treatment of potentially malignant oral disorders: a randomized, double-blind, controlled trial . International Journal of Clinical Trials. 2024 Sep; 11(3): 207-214en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/243662
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber3en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20242003en_US
dc.subjectPDTen_US
dc.subjectMethylene blueen_US
dc.subjectTreatmenten_US
dc.subjectEffectivenessen_US
dc.subjectPMODen_US
dc.titleEfficacy of 5% methylene blue photodynamic therapy in the treatment of potentially malignant oral disorders: a randomized, double-blind, controlled trialen_US
dc.typeJournal Articleen_US
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