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临床试验/CTRI/2021/03/032055
CTRI/2021/03/032055尚未招募不适用

Estimation of serum and salivary magnesium levels in individuals with habits with or without pre-malignant lesions

SGT University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To compare Magnesium levels in serum and saliva of individuals with tobacco habit and alcohol habit with and without pre-malignant lesions.

研究概览

简要总结

Oral cancer is the third-most commonform of cancer in India. The rate at which cancer will develop is dependent onthe dose, frequency, and method of application ofthe carcinogen.  The development of oral cancer is a multistepprocess arising from pre-existing potentially malignant lesions. Leukoplakia isthe most common precancer representing 85% of such lesions. It has beensuggested that a vast majority of oral squamous cell carcinomas (SCCs) in Indiaarise from pre-existing leukoplakia. Among all the risk factors, the disease ismainly associated with the use of tobacco, alcohol, viruses, radiation,and UV light. These factors can also cause disturbances in the levels ofminerals in the body fluid. Often these factors may further contribute tometabolic abnormalities like coronary heart disease, liver disease, lunginfection, kidney failure, and disorders of the endocrine system. Therefore,the primary focus has shifted to early detection of oral premalignant andmalignant conditions rather than diagnosing it at an advanced stage.

Often such pre-malignant lesions areassociated with the habit of tobacco in various forms. Dried tobacco leaves aremainly usedfor smoking in cigarettes, cigars, pipes, andshishas. They can also be consumed as snuff, chewing tobaccoand dipping tobacco. Smokeless tobacco products can be used forchewing, sucking, gargling, sniffing, and as a dentifrice. Tobacco smokingposes a risk to health due to the inhalation of poisonous carcinogens intobacco smoke. It has also been observed that many tobacco users often have ahabit of alcohol. Alcohol also has a variety of adverse effects, like generalizedimpairment of neurocognitive function, dizziness, liver and braindamage. Alcohol’s effect on the oral cavity along with the habit of tobaccoincreases the risk of developing cancer by several times. The dehydratingeffect of alcohol on the cell walls enhances the ability of tobacco carcinogensto permeate the mouth tissues, which shows a synergistic effect in the processof carcinogenesis.

Alterations in the levels of traceelements have been associated with patients with oral cancer, pre-cancer, andother disorders. Such trace elements are found in abundance in the human bodyand are involved in various physiological metabolic processes. They play amajor role in the living body by maintaining the osmotic pressure and membranepotentials. Trace elements are chemical elements required in minute amounts,usually as part of a vital element.

Magnesium is one of the most abundantcations present in the living cells. It is an essential element that isrequired for a broad variety of physiological functions and it plays animportant role as a regulator of cell functions. Serum Magnesium levels areremarkably constant in healthy participants and protect the body againstvarious diseases. Aziz NZ et al (2018) has proposed that Magnesiumdeficiency can play an important role in precancerous cell transformation.Magnesium is a critical cation and cofactor in numerous intracellularprocesses. It is involved in a large variety of biological functions, rangingfrom structural roles by complexing negatively charged groups such asphosphates in nucleic acids, a control role in enzyme activation or inhibitionand regulatory role by modulating cell proliferation, cell cycle progression,and differentiation. Any imbalances with Magnesium ion concentration have oftenbeen associated with the occurrence of a pathological condition. It has beensuggested that Magnesium deficiency may trigger carcinogenesis by altering thefidelity of DNA replication and increasing membrane permeability.

Researchers have often observed a lowMagnesium level in patients with tobacco habits due to increased demand forMagnesium by smokers owing to increased release of adrenaline and thethermogenic effect of nicotine, which is the main constituent of tobacco. Lowlevels could also result from a decreased supply in the diet and reducedabsorption caused by disturbances in the digestive system function.

Not many studies have been done toevaluate Magnesium levels in serum and saliva of patients with tobacco andalcohol habits. Hence, the purpose of this study is to evaluate and compare theMagnesium levels in serum and saliva of patients with tobacco and alcoholhabits to serve as a simple and reliable biomarker in the process ofcarcinogenesis.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients having different tobacco habits for more than a year.
  • 2.Patients having white or red lesions in their mouths.
  • 3.Patients having no habits and no pre-malignant lesions will be taken as controls.

排除标准

  • 1.Patients with any systemic disease/in comorbid condition/on radiotherapy or chemotherapy.
  • 2.Patients taking any medications.
  • 3.Pregnant or lactating women.
  • 4.Patients above 65 years.

结局指标

主要结局

To compare Magnesium levels in serum and saliva of individuals with tobacco habit and alcohol habit with and without pre-malignant lesions.

时间窗: 6 months

次要结局

  • To estimate the Magnesium levels in Serum and Saliva in individuals with tobacco habits and without pre-malignant lesions;tobacco habits and pre-malignant lesions;alcoholic individuals with tobacco habits but without pre-malignant lesions;alcoholic individuals with tobacco habits and pre-malignant lesions.(To compare the levels of Magnesium in serum with levels of Magnesium in saliva in various groups.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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