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临床试验/CTRI/2025/05/087117
CTRI/2025/05/087117尚未招募2 期

Effectiveness of photodynamic therapy using Anthocyanin-Curcumin as a photosensitizer gel in the management of oral lichen planus-A split mouth randomised control trial

Dr Dhanya M1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction in the size of the lesion

研究概览

简要总结

This study is a randomised parallel trial with a split mouth design, assessing the effectiveness of photodynamic therapy using Anthocyanin-curcumin as a photosensitizer gel. One side of the mucosa receives photodynamic therapy (PDT), whereas the other side of the same patient receives photobiomodulation therapy  (PBT) as a comparator. Totally 30 sites are included in this study. This study is conducted only in India for a period of 2 years duration and further the primary outcome is measured by reduction in the lesion size and the secondary outcome is measured by assessing the reduction in pain score.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • clinically and Histopathologically confirmed cases of all forms of Oral lichen planus
  • Bilateral presentation of the lesions.

排除标准

  • Patients with other oral potentially malignant disorders are excluded.
  • Patients with Unilateral clinical presentation of oral lichen planus are excluded.
  • Patients with oral Lichenoid reactions are excluded.

结局指标

主要结局

Reduction in the size of the lesion

时间窗: 2 years

次要结局

  • Reduction is burning sensation(2 years)

研究者

发起方
Dr Dhanya M
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Dhanya

Saveetha Dental college and Hospitals

研究点 (1)

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