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CTRI Number  CTRI/2021/03/032055 [Registered on: 17/03/2021] Trial Registered Prospectively
Last Modified On: 15/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To compare magnesium levels in serum and saliva of individuals with tobacco habit and alcohol habit with and without pre-malignant lesions 
Scientific Title of Study   Estimation of serum and salivary magnesium levels in individuals with habits with or without pre-malignant lesions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ishita Singhal 
Designation  PG student 
Affiliation  SGT University 
Address  Room no.9, Department of Oral Pathology and Microbiology and Forensic Odontology, Faculty of Dental Sciences, SGT University

Gurgaon
HARYANA
122505
India 
Phone  8745002123  
Fax    
Email  drishita21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manpreet Arora 
Designation  Professor 
Affiliation  SGT University 
Address  Room no.9, Department of Oral Pathology and Microbiology and Forensic Odontology, Faculty of Dental Sciences, SGT University

Gurgaon
HARYANA
122505
India 
Phone  9871173531  
Fax    
Email  manpreet.arora@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Manpreet Arora 
Designation  Professor 
Affiliation  SGT University 
Address  Room no.9, Department of Oral Pathology and Microbiology and Forensic Odontology, Faculty of Dental Sciences, SGT University

Gurgaon
HARYANA
122505
India 
Phone  9871173531  
Fax    
Email  manpreet.arora@sgtuniversity.org  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Sciences, SGT University, Gurugram-122505 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ishita Singhal  SGT University  Room no.9, Department of Oral Pathology and Microbiology and Forensic Odontology, Faculty of Dental Sciences
Gurgaon
HARYANA 
8745002123

drishita21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURGAON  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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. 
6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

Often such pre-malignant lesions are associated with the habit of tobacco in various forms. Dried tobacco leaves are mainly used for smoking in cigarettes, cigars, pipes, and shishas. They can also be consumed as snuff, chewing tobacco and dipping tobacco. Smokeless tobacco products can be used for chewing, sucking, gargling, sniffing, and as a dentifrice. Tobacco smoking poses a risk to health due to the inhalation of poisonous carcinogens in tobacco smoke. It has also been observed that many tobacco users often have a habit of alcohol. Alcohol also has a variety of adverse effects, like generalized impairment of neurocognitive function, dizziness, liver and brain damage. Alcohol’s effect on the oral cavity along with the habit of tobacco increases the risk of developing cancer by several times. The dehydrating effect of alcohol on the cell walls enhances the ability of tobacco carcinogens to permeate the mouth tissues, which shows a synergistic effect in the process of carcinogenesis.

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

Magnesium is one of the most abundant cations present in the living cells. It is an essential element that is required for a broad variety of physiological functions and it plays an important role as a regulator of cell functions. Serum Magnesium levels are remarkably constant in healthy participants and protect the body against various diseases. Aziz NZ et al (2018) has proposed that Magnesium deficiency can play an important role in precancerous cell transformation. Magnesium is a critical cation and cofactor in numerous intracellular processes. It is involved in a large variety of biological functions, ranging from structural roles by complexing negatively charged groups such as phosphates in nucleic acids, a control role in enzyme activation or inhibition and regulatory role by modulating cell proliferation, cell cycle progression, and differentiation. Any imbalances with Magnesium ion concentration have often been associated with the occurrence of a pathological condition. It has been suggested that Magnesium deficiency may trigger carcinogenesis by altering the fidelity of DNA replication and increasing membrane permeability.

Researchers have often observed a low Magnesium level in patients with tobacco habits due to increased demand for Magnesium by smokers owing to increased release of adrenaline and the thermogenic effect of nicotine, which is the main constituent of tobacco. Low levels could also result from a decreased supply in the diet and reduced absorption caused by disturbances in the digestive system function.

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

 

 
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