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

Not yet recruiting

Conditions: Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,

Registration Number: CTRI/2021/03/032055

Lead Sponsor: SGT University

Brief Summary: 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. Alcoholâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Magnesium levels in serum and saliva of individuals with tobacco habit and alcohol habit with and without pre-malignant lesions.	6 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): SGT University
🇮🇳
Gurgaon, HARYANA, India
SGT University
🇮🇳Gurgaon, HARYANA, India
Dr Ishita Singhal
Principal investigator
8745002123
drishita21@gmail.com