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
Dr Dhanya
Saveetha Dental college and Hospitals
研究点 (1)
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