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
|
|
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
|
|
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
|
|
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
|
|
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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