Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension
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
- length of oral lichen planus
研究概览
简要总结
Lesions of the lichen planus type within the oral mucosa are now considered a potentially cancerous condition. One of the minimally invasive methods of treating these lesions is photodynamic therapy, and the gold standard in therapy is topical steroid administration
详细描述
Lichen planus shows an irregular shape, which is quite difficult to measure objectively, which is important in assessing the effectiveness of treatment.
Patients will be treated in protocol split mouth with the treatment of lesions on one cheek with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot sensitizer in the form of a methylene blue also on an adhesive plaster The treatment evaluation procedure will consist of taking a series of intraoral photographs. These photos will be taken at each visit. This procedure will involve taking pictures traditionally in "white" light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique feature of the prototype laser - emission of two wavelengths simultaneously) in order to induce autofluorescence of the mucosa and treated lesions to better visualize them
A prospective, randomized, single-blind 12-week clinical trial of full contralateral split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using methylene blue in four sessions every 2 days.
olp on the other side was treated with the administration of the steroid triamcinolone for 8 days
The clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the next 11 weeks
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
- •histological diagnosis of OLP
- •non smoker
- •no diabetes melitus
- •no hepatitis
排除标准
- •diabetes melitus
- •hepatitis
- •occurrence dysplasia in the histopathological specimen;
- •use of lichenoid reaction inducing medication 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: PDT Therapy (Device)
Triamcinolone (Substance) therapy 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 (Substance) therapy side (Drug)
结局指标
主要结局
length of oral lichen planus
时间窗: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the length of the lesions
height of oral lichen planus
时间窗: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the height
次要结局
- computer analysis of autofluorescence of lesions(12 weeks)