Assessment Of Efficacy Of Topical Oromucosal Paste Containing 10% Nigella Sativa Vs 10% Curcumin Vs 0.1 % Triamcinolone Acetonide In Management Of Symptomatic Oral Lichen Planus - A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disorder associated with pain, burning sensation, and erosive oral lesions, which significantly affect patients’ quality of life. Conventional management primarily involves topical corticosteroids such as triamcinolone acetonide; however, their long-term use is associated with adverse effects, necessitating safer and effective alternatives. Natural agents like Nigella sativa and curcumin possess anti-inflammatory, antioxidant, immunomodulatory, and antineoplastic properties and have shown promising results in oral mucosal diseases.
This randomized controlled clinical trial aims to assess and compare the efficacy of 10% topical Nigella sativa oromucosal paste and 10% topical curcumin oromucosal paste with 0.1% topical triamcinolone acetonide in the management of symptomatic oral lichen planus. A total of 90 clinically and histopathologically confirmed OLP patients will be randomly allocated into three groups (30 patients each). Group A will receive 10% Nigella sativa paste, Group B will receive 10% curcumin paste, and Group C will receive 0.1% triamcinolone acetonide paste, applied 3–4 times daily for four weeks.
Patients will be evaluated weekly for subjective symptoms (pain and burning sensation) using the Visual Analog Scale (VAS) and objective clinical improvement using the Thongprasom grading system. The outcomes of this study may help establish Nigella sativa and curcumin as effective and safer therapeutic alternatives or adjuncts to conventional corticosteroid therapy in the management of symptomatic 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
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically and histopathologically proven cases of symptomatic Oral lichen planus.
- •Individuals within the age group of 20-60 years.
- •Both genders.
- •Willingness to participate in the study.
排除标准
- •Histopathologically proven OLP with dysplastic changes.
- •Not willing to participate in study Previously treated cases of Oral lichen planus Lactating or pregnant women Allergic patients, immunocompromised patients, systemic illness Asymptomatic patients.
研究者
Dr Bakyalakshmi V
Tamil Nadu Government Dental College And Hospital
