"Salivary Levels of Cathelicidin LL-37 in Patients With Oral Potentially Malignant Lesions, A Case Control Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA
研究概览
简要总结
LL-37 appears to have a potential role in potentially malignant lesions (OLP & leukoplakia). The remarkable diagnostic accuracy of salivary LL-37 in differentiating potentially malignant lesion and healthy control could confirm its utilization as an innovative marker to early diagnose potentially malignant lesions. Salivary LL-37 being non-invasive accurate marker could be as a chair-side diagnostic method that detect potentially malignant lesions.
详细描述
Aim: The recognition of practical early diagnostic biomarkers is a cornerstone of improved prevention and treatment of cancer thus the current study estimated salivary level of Cathelicidin LL-37 in patients suffering from potentially malignant lesions and control subjects to corroborate Cathelicidin LL-37 as a diagnostic marker for early detection of potentially malignant diseases and revealing its possible role in carcinogenesis.
Methodology: 45 systemically healthy individuals were subdivided into three groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia.. Enzyme linked immune-sorbent assay (ELIZA) kit was used to evaluate the level of LL-37 in whole unstimulated salivary samples collected from all participants. To reveal AUC, sensitivity, specificity, and diagnostic accuracy of LL-37 receiver operating curve (ROC) analysis was done.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders with age range 30 - 70 years.
- •Patients agreed to sign a written consent after understanding the nature of the study.
- •Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions mainly atrophic/erosive oral lichen planus and oral leukoplakia.
排除标准
- •Systemic diseases as well as pregnant or lactating females.
- •Patients currently taking corticosteroids, immunosuppressives drugs, contraceptive pills, or antibiotics.
- •Patients are diagnosed with any other oral lesions other than oral lichen planus and oral leukoplakia.
- •Vulnerable subjects as prisoners, or mentally disabled.
结局指标
主要结局
Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA
时间窗: level of LL-37 is measured after the completion of all sample collection carried at the 1 day of enrollement of subjects in the investigation after diagnosis confirmation
ELISA is used to estimate Cathelicidin LL-37 levels in saliva samples from patients with OPMD compared to healthy subjects
次要结局
未报告次要终点
研究者
Sandy Hassan
Associate professor oral medicine & periodontology departement
Fayoum University