Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus (A Randomized Controlled Clinical Trial With Biochemical Analysis)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- clinical score
研究概览
简要总结
In oral lichen planus ,Tumor necrosis factor-alpha (TNF-α) has a role in the progression of the disease, enhancing CD8+ cytotoxic T cells and plays a role in the malignant transformation of the lesion. IL-10 is an anti-inflammatory cytokine that controls the disease and maintain homeoastasis. Treatment for OLP includes corticosteroids which is the gold standard, although they have considerable side effects. The use of herbal medicine as an alternative therapy seems promising. Coconut oil has anti-inflammatory, antioxidant, and immunomodulatory properties, no adverse effects, easily available, cost-effective and simply extracted.The aim of this randomized controlled clinical trial is to compare the therapeutic effects of topical 50% coconut mucobioadhesive gel versus topical corticosteroid gel in the management of symptomatic OLP clinically and using biochemical analysis
详细描述
Patients with symptomatic OLP will be recruited in the study. Group 1, containing 15 patients will receive topical coconut oil while Group 2 containing 15 patients will receive topical corticosteroid four times per day for a period of 8 weeks. Clinical assessment including clinical score, area of marker lesion and visual analogue scale will be compared between the two groups. Salivary samples from patients in the two groups will be collected at baseline and after 8 weeks to assess the level of TNF-α and IL-10 biochemically using ELISA.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and histologically proven Bullous/erosive or atrophic forms of OLP.
排除标准
- •lichenoid lesions.
- •Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
- •Known hypersensitivity to the treatment drugs or any of the ingredients.
- •Pregnancy or breast-feeding.
- •History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs in the last 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
- •Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- •Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- •Vulnerable groups (handicapped, orphans and prisoners).
研究组 & 干预措施
Topical coconut gel (50%)
topical coconut gel (50%) four times per day (after every meal and before going to bed) for eight weeks
干预措施: Coconut oil (Other)
Topical corticosteroid
topical corticosteroid (triamcinolone acetonide 0.1%) four times per day for eight weeks
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
clinical score
时间窗: change from baseline two, four, eight and 12 weeks
0: represented no lesion/normal mucosa 1. mild white striae/no erythematous area 2. white striae with atrophic area less than 1 cm2 3. white striae with atrophic area more than 1 cm2 4. white striae with erosive area less than 1 cm2 5. white striae with erosive area more than 1 cm2
次要结局
- salivary levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10)(The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period)
研究者
Shahenda Mahmoud Farid Mahmoud
Assistant lecturer of oral medicine and periodontology department
Ain Shams University