A Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus- Split-Mouth Randomised
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Size of Oral lichen planus
研究概览
简要总结
Lichen planus is a chronic inflammatory dermatosis. It most often affects the skin and mucous membranes. Sometimes lesions may appear in the area of nails (estimated at 10% of patients) or genital organs and anus.
The most dangerous form of lichen planus is lichen that develops on the oral mucosa. It is believed to be the cause of the development of oral cancer.
The vast majority of people suffering from lichen planus - 90%, experience spontaneous resolution of symptoms within a maximum of two years from the moment of their onset.
In about half of the patients, the changes disappear within about 6 months. People who have a problem that their ailments do not want to go away on their own must take into account the fact that treating lichen is not the easiest one.
Treatment of lichen is mainly based on alleviating its symptoms and accelerating the resolution of symptoms. Topical ointments containing strong glucocorticosteroids are usually applied to skin lesions or we can use Photodynamic Therapy
详细描述
Oral lichen planus is most often characterized by lesions resembling a painless white mesh, which is usually located on the inside of the cheeks and the sides of the tongue. Lumps, erosions or erythematous changes are less often noticeable.
Symptoms in oral lichen planus are often:
reddening, dry mouth baking, swelling and minor bleeding.
Sometimes the gum mucosa exfoliates. When erosions occur, patients complain of pain and problems with drinking and swallowing food. Oral lesions necessarily require treatment.
Since lichen planus comes in many forms, some of them require histopathological examination to identify some of them. These tests involve taking a slice of the affected skin and examining it under a microscope.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having a histological diagnosis of OLP
- •non smoker
- •without diabetes melitus
- •without hepatitis
排除标准
- •diabetes melitus
- •hepatitis
- •occurrence dysplasia in the histopathological specimen;
- •use of lichenoid reaction inducing medications and presence of amalgam fillings nearby the lesions;
- •interventions for OLP in the previous 12 weeks;
- •pregnant or breastfeeding women;
- •proved or suspected hypersensitivity to any of the chemicals used in the treatment
研究组 & 干预措施
photodynamic therapy side
On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy in four sessions every 2 days.Using as photosensitizer Methylen blue for 10min the lesion was irradiated with a 650 nm semiconductor laser at a dose of 120 J / cm2
干预措施: Photodynamic Therapy (Procedure)
Steroid side
on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Size of Oral lichen planus
时间窗: 12 weeks
the size of the oral lichen planus on oral mucosa in millimeters was assessed using a periodontal probe PCPUNC 15 we measured the height and length of the lesions
次要结局
- Pain rating(12 weeks)