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OpenTrials
Completed

NCT Number: NCT04267419

Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

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.

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Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

salivary biomarker

Diagnostic Test

MDA and NO as salivary biomarkers

Primary outcomes

  1. Salivary MDA level in different oral lesions

    Time frame: 9 months

    The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.

  2. Salivary NO level in different oral lesions

    Time frame: 9 MONTHS

    The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2020
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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