A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
研究概览
简要总结
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.
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, Care Provider)
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
- •Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- •Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
- •Oral Lichen planus SIN III (diagnostics by Biopsie)
- •Good mouth hygiene status (tartar, surface)
- •Correct seat of the prosthesis and/or the denture
- •Located erosions in the oral cavity
- •Minimum age:18 years
- •Women at the age capable of child-bearing with an appropriate contraception
排除标准
- •Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
- •Pregnancy
- •less than 18
- •Satisfying women
- •No tobacco abuse
- •satisfying therapy with local immunmodulators in lichen ruber
- •surgical therapy of leukoplakia indicated
结局指标
主要结局
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
时间窗: each treatment average once a week, recall after 4 weeks
次要结局
- pain due to treatment, assessed by visual analogue scale (VAS)(each treatment, average once a week)
研究者
Dvorak Gabriella
Univ.Ass.DDr., senior staff at department of oral surgery
Medical University of Vienna