Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Study Overview
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Brief Summary
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investigating the level of malondialdehyde (MDA) & nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.

Detailed Description
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Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6). In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6). Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions

Official Title
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Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Conditions
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Oral Lichen Planus, Oral Cancer, Leukoplakia, Oral Keratoses

Intervention / Treatment
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* Diagnostic Test: salivary biomarker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy individuals with one of the following oral lesions : keratosis Oral lichen planus oral squamous cell carcinoma oral leukoplakia Exclusion Criteria: subjects having systemic disorders pregnant or lactating females; subjects who suffered from any other mucosal lesions; severe periodontal inflammation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy Control<br>MDA and NO in saliva | Diagnostic Test: salivary biomarker<br>* MDA and NO as salivary biomarkers<br>|
| keratosis<br>MDA and NO in saliva | Diagnostic Test: salivary biomarker<br>* MDA and NO as salivary biomarkers<br>|
| leukoplakia<br>MDA and NO in saliva | Diagnostic Test: salivary biomarker<br>* MDA and NO as salivary biomarkers<br>|
| Oral lichen Planus<br>MDA and NO in saliva | Diagnostic Test: salivary biomarker<br>* MDA and NO as salivary biomarkers<br>|
| oral Squamous cell carcinoma<br>MDA and NO in saliva | Diagnostic Test: salivary biomarker<br>* MDA and NO as salivary biomarkers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary MDA level in different oral lesions | The MDA level in saliva measured using ELISA kit provided by My BioSource, USA. | 9 months | 
| Salivary NO level in different oral lesions | The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA. | 9 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malondialdehyde, nitric oxide, salivary biomarkers