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临床试验/NCT03830710
NCT03830710已完成不适用

Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions

Fayoum University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
salivary TAC

研究概览

简要总结

Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with healthy control subjects were included. Salivary samples from all participants were collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a photometric test system.

详细描述

Detection of molecular markers in saliva is superior to their detection in serum and other body fluids due to the fact of being an easy non-invasive tool requiring no training for its collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in premalignant and malignant patients compared to normal subjects and to determine their diagnostic value for the malignant patients.

Methodology:

Study population:

A total of 120 subjects were enrolled in the present study. The clinically tested and confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30 patients suffering from oral lichen planus Group C: 30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site Group D: 30 age and gender matched individuals having no oral mucosal lesions acting as a control group.

Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens were obtained from various lesions where a surgical double wedge incisional biopsy was carried out to a depth of about 2mm. Specimens were sent for histopathological examination to confirm the clinical diagnosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
35 Years 至 63 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All included individuals were not under any current medication, suffering from any systemic condition or having any other oral mucosal disorder.

排除标准

  • Pregnant or lactating females
  • subjects having systemic disorder or taking medications;
  • subjects who suffer from any other mucosal lesions.
  • severe periodontal inflammation

结局指标

主要结局

salivary TAC

时间窗: 1 year

OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades

Salivary 8-OHdG

时间窗: 1 year

8-OHdG have a critical role in the pathogenesis of malignant lesions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandy Hassan

lecturer

Fayoum University

研究点 (1)

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