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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer; Leukoplakia; Oral Lichen Planus; Oral Keratoses
• Intervention / Treatment: Diagnostic test: salivary biomarker

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Maha Abdelkawy, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

out patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy Control; MDA and NO in saliva	Diagnostic test: salivary biomarker; MDA and NO as salivary biomarkers
keratosis; MDA and NO in saliva	Diagnostic test: salivary biomarker; MDA and NO as salivary biomarkers
leukoplakia; MDA and NO in saliva	Diagnostic test: salivary biomarker; MDA and NO as salivary biomarkers
Oral lichen Planus; MDA and NO in saliva	Diagnostic test: salivary biomarker; MDA and NO as salivary biomarkers
oral Squamous cell carcinoma; MDA and NO in saliva	Diagnostic test: salivary biomarker; MDA and NO as salivary biomarkers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: weam Elbattawy, Phd, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: nitric oxide; malondialdehyde; salivary biomarkers
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Precancerous Conditions; Lichenoid Eruptions; Keratosis; Mouth Neoplasms; Leukoplakia; Leukoplakia, Oral; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: FDBSUREC/17022019/AM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all the data will shared once the work is published
• IPD Sharing Time Frame: once published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No