Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Completed

• Conditions: Oral Lichen Planus; Oral Keratoses; Oral Cancer; Leukoplakia
• Interventions: Diagnostic Test: salivary biomarker

• Registration Number: NCT04267419
• Lead Sponsor: Beni-Suef University

Brief Summary

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

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

Study Timeline

• Study Start: 2019-02-18
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• healthy individuals with one of the following oral lesions :

  • keratosis
  • Oral lichen planus
  • oral squamous cell carcinoma
  • oral leukoplakia

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Exclusion Criteria

• subjects having systemic disorders
• pregnant or lactating females;
• subjects who suffered from any other mucosal lesions;
• severe periodontal inflammation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral lichen Planus	salivary biomarker	MDA and NO in saliva
leukoplakia	salivary biomarker	MDA and NO in saliva
healthy Control	salivary biomarker	MDA and NO in saliva
oral Squamous cell carcinoma	salivary biomarker	MDA and NO in saliva
keratosis	salivary biomarker	MDA and NO in saliva

Primary Outcome Measures

Name	Time	Method
Salivary MDA level in different oral lesions	9 months	The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.
Salivary NO level in different oral lesions	9 MONTHS	The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.

Trial Locations

Locations (1)

Maha Abdelkawy, Phd; 🇪🇬 Cairo, Egypt