Oral Lichen Planus Photodynamic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change Thongprasom sign scoring
研究概览
简要总结
Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin
In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared
详细描述
In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.
This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.
排除标准
- •Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity
结局指标
主要结局
Change Thongprasom sign scoring
时间窗: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions \< 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2
Change Assessment of Pain of OLP
时间窗: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
次要结局
未报告次要终点
研究者
Pia Lopez Jornet
Investigador principal Head Oral Medicine
Universidad de Murcia