CTRI/2024/12/077829尚未招募不适用
Comparative evaluation of Salivary Lactate Dehydrogenase, Ferritin and Matrix Metalloproteinase-9 Biomarkers and role of expression of Programmed Death-1 and programmed Death Lignand-1 in Oral Submucous Fibrosis- A Case control study
Dr kavita wadde1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年12月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the significant role of Salivary LDH, MMP-9 and Ferritin in screening and early
研究概览
简要总结
- In our research, saliva is being employed as a diagnostic medium due to its non-invasive nature, portability, and suitability for large-scale population screening.
- The biomarkers used in the study are lactate dehydrogenase, matrix metalloproteinase-9, and ferritin in saliva in oral submucous fibrosis. The sample collected is saliva, which is near the site of the lesion. Their presence at the site of lesion is a sign of cellular damage and can be helpful in the early detection and progression of the disease.
- As oral submucous fibrosis is a potentially malignant disorder, proper patient follow-up is crucial to prevent its progression into malignancy. Therefore, reliable biomarkers are essential for early detection and disease progression. We are estimating the levels of biomarkers in saliva, which can be helpful in mass screening and in determining the prognosis of the treatment given.
- The expression of PD and PD-L1 in OPMDs may indicate a potential for malignant transformation. PD and PD-L1 assist cells in evading immune checkpoints and promote tumor cells proliferation. Early detection of PD and PD-L1 expression in oral submucous fibrosis can lead to a better prognosis, and regular testing can help to monitor disease progression. This advanced method of genetic-level detection contributes to a better understanding of the disease mechanism
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
- 22.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of the age group 25-55 years were included in the study.
- •Patients consuming gutka, areca nut chewing habit.
- •Healthy patients without habit or any disease, healthy patients with habit without any disease.
- •Patients with clinically diagnosed and histopathological confirmed Oral Submucous Fibrosis.
- •Patients who have not received any prior treatment for Oral Submucous Fibrosis.
- •Patients without any TMJ disorders or any history of trauma.
排除标准
- •Patients with systemic diseasesto alterserum LDH levelssuch as Myocardial Infarction, Liver disease, Pulmonary disorders, Renal disorders and Muscle dystrophy.
- •Immunocompromised patients
- •Patients who have a habit of smoking cigarettes.
- •Patients under corticosteroid therapy
- •Patientsreceiving iron supplements.
- •Patients with other mucosal lesions other than OSMF.
- •Any Oral and Maxillofacial infections and any salivary disorders.
结局指标
主要结局
To evaluate the significant role of Salivary LDH, MMP-9 and Ferritin in screening and early
时间窗: Assessment will be done at the baseline at the time of collection of samples
detection of Oral Submucous Fibrosis and also evaluate the expression of PD-1 and PD-L1 in
时间窗: Assessment will be done at the baseline at the time of collection of samples
Oral Submucous Fibrosis.
时间窗: Assessment will be done at the baseline at the time of collection of samples
次要结局
- It can be used as screening mass population in precancerous conditions(assessment will be done at baseline at the time sample collection)
研究者
Dr kavita wadde
Government Dental College and Hospital Mumbai
研究点 (1)
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