Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in lesion size
研究概览
简要总结
Oral leukoplakia (OL) is recognized as the most common potentially malignant disorder of the oral mucosa. The pathogenesis of OL is complex and multifactorial, with oxidative stress playing a central role. Topical antioxidants have gained attention as therapeutic options to help stabilize lesions and potentially prevent malignant transformation. Both CoQ10 and curcumin have demonstrated a clinical success as strong antioxidants showing their capacity to reduce the lesion size and to stabilize the disease, ultimately preventing progression into oral malignancy. Aim: This study aims to clinically and biochemically assess the effectiveness of topical Coenzyme Q10 and Curcumin in the management of homogeneous oral leukoplakia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision .
- •Lesions accessible for topical application.
- •Willing to sign informed consent and comply with study instructions and return to follow up
排除标准
- •Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer.
- •Presence of any visible oral lesions except for oral leukoplakia.
- •Active periodontal diseases as this can confound salivary biomarkers.
- •Significant systemic illness or immunosuppression.
- •Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers.
- •Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations.
- •Patients unwilling or unable to comply with study requirements.
研究组 & 干预措施
Topical curcumin gel
干预措施: Topical curcumin gel (Other)
Topical Coenzyme Q10 gel
干预措施: Coenzyme Q10 gel (Other)
结局指标
主要结局
Change in lesion size
时间窗: baseline, 4 weeks, and 12 weeks
measured clinically with a periodontal probe and/or digital images
次要结局
- Change in salivary markers(baseline, 4 weeks, and 12 weeks)