COMPARATIVE EVALUATION OF EFFICACY OF INTRALESIONAL LOW MOLECULAR WEIGHT HEPARIN, INTRALESIONAL INJECTION OF TRIAMCINOLONE ACETONIDE AND PHOTO-BIOMODULATION IN ORAL LICHEN PLANUS: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- reduction in burning sensation measured by visual analog scale and clinical improvement in lesion size and appearance measured by thongprasom scoring criteria and improvement in quality of life which is measured by American chronic pain association
研究概览
简要总结
Oral lichen planus is a chronic inflammatory disease that commonly affect the skin and the oral mucosa although the mucous membrane such as conjuctiva, oesophagus and genitalia can also be affected with predominance towards the middle age female patients cause burning sensation pain, and discomfort significantly affecting patient quality of life.Corticosteroid have been considered the first choice agent for the management of OLP. Corticosteroids are especially helpful in the management of OLP in view of their anti-inflammatory effect and anti-immunological properties . Intralesional injection of Triamcinolone acetonide has shown successful result in oral lichen planus however continuous and prolonged use is associated with many systemic adverse effect such as bad taste, nausea, facial swelling, dryness, mucosal atrophy, candida infection, granuloma formation, hypersensitivity reaction, delayed wound healing, and in later stages; hypothalamus pituitary adrenal suppression.Due to serious side effects encountered during long term use of corticosteroids alternative therapies are tried, one among them are Low molecular weight heparin . Heparin is an anticoagulant that inhibits the development and progression of clot formation. Low molecular weight heparin in low doses has lymphoid antiproliferative and immunomodulatory properties. Another treatment option is Photobiomodulation (PBM), in which a laser (at 630 to 980nm wavelength, output power of 20 to 300 mW and an exposure time of 10 s to 15 min) is used to beneficially influence cell metabolism, without harm to the cells.The present study is an effort to evaluate the therapeutic effect of low molecular weight heparin(Enoxaparin) intralesional injections, photobiomodulation and comparing it with intralesional injection of steroids, and also is an effort to understand the adverse effect of these therapeutic modalities & any effect on relapse/ recurrence of oral lichen planus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Above 18 years of age.
- •Patients clinically diagnosed with symptomatic oral lichen planus.
- •Patients who will give consent for the treatment.
排除标准
- •Hospitalized patients and pregnant females.
- •Kidney and liver failure patients.
- •History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer.
- •Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.
结局指标
主要结局
reduction in burning sensation measured by visual analog scale and clinical improvement in lesion size and appearance measured by thongprasom scoring criteria and improvement in quality of life which is measured by American chronic pain association
时间窗: 6 month and 1 year
次要结局
- Recurrence rate(6 months after completion of treatment)
研究者
DR SIMRAN JEET SINDHU
subharti dental college and hospital