The Effectiveness Of Vitamin D Supplementation In The Therapeutic Management of Oral Lichen Planus In Adults- A Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Disease severity 1.Reduction using the ODSS( Oral Disease Severity Scale) and REU scoring system
研究概览
简要总结
This is a crossover non-randomized controlled trial conducted at the Department of Oral Medicine and Radiology, Government Dental College, Kozhikode, over 18 months. Patients aged 18 years and above with histopathologically confirmed OLP and serum vitamin D levels below 30 ng/ml will be included. Exclusion criteria include systemic immunosuppressive therapy, pregnancy, and systemic comorbidities. Participants will be categorized into Group A (less than 20 ng/ml) and Group B (20 to 29 ng/ml).
In Month 1, Group A receives vitamin D (60000 IU per week), corticosteroids, and antioxidants; Group B receives corticosteroids and antioxidants only.
In Month 2, a crossover occurs. Group B now receives vitamin D, while Group A discontinues it. Follow-ups every two weeks will assess disease severity using ODSS and REU scoring systems and pain using the VAS scale.
Quality of life will be assessed before treatment and six months after treatment using the 15-point COMDQ
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged above 18 years, diagnosed with Oral Lichen Planus (OLP) based on the clinical and histopathological features and with serum vitamin D levels less than 30 ng per ml will be included in the study.
排除标准
- •Age less than 18 years
- •Current systemic steroid or immunosuppressive therapy for OLP
- •Oral lichenoid contact reactions caused by dental materials or lichenoid drug reactions
- •Pregnancy or lactation
- •Presence of any other oral mucosal lesions
- •Patients with diseases like Chronic renal disease and CVA and CAD
- •Debilitated patients.
结局指标
主要结局
1. Disease severity 1.Reduction using the ODSS( Oral Disease Severity Scale) and REU scoring system
时间窗: outcome assessed at 2 weeks ,4weeks,6 weeks,8 weeks
2.Pain reduction using the VAS Scale
时间窗: outcome assessed at 2 weeks ,4weeks,6 weeks,8 weeks
次要结局
未报告次要终点
研究者
Dr Jeyapriya G
Government Dental College Kozhikode