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Objectives <p>Oral candidiasis is a common oral mucosal infection, and limitations of conventional antifungal therapy highlight the need for alternative chairside treatment approaches. This study aimed to assess the short-term clinical response, safety, and feasibility of a chairside methylene blue-mediated photodynamic therapy (MB-PDT) protocol for oral candidiasis, and to generate preliminary data to inform the design of future randomized controlled trials.</p> Methods <p>This prospective, randomized, open-label, exploratory controlled trial enrolled patients with clinically and mycologically confirmed oral candidiasis between September 2024 and September 2025. Participants were block-randomized into two groups: the MB-PDT group (<i>n</i> = 9), which received chairside MB-PDT using the Periowave<sup>®</sup> systemor, and the nystatin group (<i>n</i> = 9), which received nystatin lozenges (500,000 IU per lozenge). MB-PDT was administered three times weekly for two weeks, while nystatin lozenges were taken three times daily for two weeks. Clinical outcomes, mycological outcomes, comprehensive response, adverse events, treatment adherence, and follow-up completion were assessed over 14 days.</p> Results <p>Eighteen participants were enrolled, with no significant baseline differences between groups (all <i>P</i> &gt; 0.05). Both groups showed marked improvement in clinical symptoms and mucosal signs. Clinical response rates were 66.7% in the MB-PDT group and 88.9% in the nystatin group (<i>P</i> = 0.576). Mycological clearance rates were 44.4% and 88.9%, respectively (<i>P</i> = 0.131). Comprehensive response rates reached 88.9% in the MB-PDT group and 100.0% in the nystatin group (<i>P</i> = 0.094). No serious adverse events were reported. Two participants withdrew, yielding an overall dropout rate of 11.1%, with good treatment adherence.</p> Conclusions <p>Chairside MB-PDT using a portable Periowave<sup>®</sup> system was feasible and well tolerated in this pilot randomized trial, while its antifungal efficacy requires further evaluation in larger studies.</p> Trial Registration <p>Chinese Clinical Trial Registry ID ChiCTR2400088856. Registration Date 28 August 2024.</p>

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Clinical feasibility of chairside methylene blue-mediated photodynamic therapy for oral candidiasis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月27日

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  • Peiru Zhou,
  • Furong Yang,
  • Jiakun Fang,
  • Jiangli Zheng,
  • Yanhong Meng,
  • Xu Zhang,
  • Hong Hua

摘要

Objectives

Oral candidiasis is a common oral mucosal infection, and limitations of conventional antifungal therapy highlight the need for alternative chairside treatment approaches. This study aimed to assess the short-term clinical response, safety, and feasibility of a chairside methylene blue-mediated photodynamic therapy (MB-PDT) protocol for oral candidiasis, and to generate preliminary data to inform the design of future randomized controlled trials.

Methods

This prospective, randomized, open-label, exploratory controlled trial enrolled patients with clinically and mycologically confirmed oral candidiasis between September 2024 and September 2025. Participants were block-randomized into two groups: the MB-PDT group (n = 9), which received chairside MB-PDT using the Periowave® systemor, and the nystatin group (n = 9), which received nystatin lozenges (500,000 IU per lozenge). MB-PDT was administered three times weekly for two weeks, while nystatin lozenges were taken three times daily for two weeks. Clinical outcomes, mycological outcomes, comprehensive response, adverse events, treatment adherence, and follow-up completion were assessed over 14 days.

Results

Eighteen participants were enrolled, with no significant baseline differences between groups (all P > 0.05). Both groups showed marked improvement in clinical symptoms and mucosal signs. Clinical response rates were 66.7% in the MB-PDT group and 88.9% in the nystatin group (P = 0.576). Mycological clearance rates were 44.4% and 88.9%, respectively (P = 0.131). Comprehensive response rates reached 88.9% in the MB-PDT group and 100.0% in the nystatin group (P = 0.094). No serious adverse events were reported. Two participants withdrew, yielding an overall dropout rate of 11.1%, with good treatment adherence.

Conclusions

Chairside MB-PDT using a portable Periowave® system was feasible and well tolerated in this pilot randomized trial, while its antifungal efficacy requires further evaluation in larger studies.

Trial Registration

Chinese Clinical Trial Registry ID ChiCTR2400088856. Registration Date 28 August 2024.