Elemental analysis of saliva, serum and oral tissue in individuals with habitual use of areca nut, betel quid and commercially packed tobacco
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- concentration of Individual elements in saliva, blood, oral tissue, chewing products.
研究概览
简要总结
Rationale/ gaps in existing knowledge: There seems to exist knowledge gap in the link between elements and oral cancer occurrence, severity, and prognosis. This study aims to qualitatively characterize the presence of elements in individuals with oral cancer, chewing products consumed and healthy controls. and verify the possible association of these elements with the occurrence and severity of OMPDs and oral cancer.
Novelty: Currently, there are no studies to evaluate the elemental composition of the chewing products (Arecanut, Betel quid, Gutkha) and relate them with the elemental composition of saliva, blood and oral tissues of chewers which is the major aim of this study.More importantly, this study makes use of Laser induced breakdown spectroscopy (LIBS) for elemental analysis in chewing products as well as body fluids and tissues which has NEVER BEEN used in previous studies in this context.
Objectives: To correlate the elements in areca nut, betel quid and commercially packed tobacco used by habitual individuals with the presence of elements in their saliva, serum, and oral tissue using Laser induced breakdown spectroscopy (LIBS).
Methods: Elemental composition in habitual chewing products and their presence in saliva, blood and oral tissue using novel spectroscopic technique.
Expected outcome: Insights into the role of elements (early diagnostic marker) in causing oral potentially malignant disorders and cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are current users of areca nut, betel quid and commercially packed form of tobacco.
- •Subjects having OMPDs or malignant lesion in the oral cavity.
排除标准
- •Subjects using smoked form of tobacco.
- •Patients currently on any kind of antioxidant therapy or mineral dietary supplements (Ca, Fe, Zn etc.).
- •Where sample collection is not feasible or patient not willing to consent.
- •Patients without remarkable medical history (suffering from systemic illnesses).
结局指标
主要结局
concentration of Individual elements in saliva, blood, oral tissue, chewing products.
时间窗: 6 months chewing products. | 12 months saliva | 18 months serum | 24 months oral tissue.
次要结局
- mapping of elemental composition between chewing product and its presence in body fluids and tissues.(6 months for chewing products.)
研究者
Salian Varsha Vittal
Department of Oral Medicine and Radiology