Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT04267419
Collaborator
(none)
100
1
9.9
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
Actual Study Start Date :
Feb 18, 2019
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Salivary MDA level in different oral lesions [9 months]

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

  2. Salivary NO level in different oral lesions [9 MONTHS]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maha Abdelkawy, Phd Cairo Egypt 11553

Sponsors and Collaborators

  • Beni-Suef University

Investigators

  • Principal Investigator: weam Elbattawy, Phd, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maha Abdelkawy, Phd, principle investigator, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT04267419
Other Study ID Numbers:
  • FDBSUREC/17022019/AM
First Posted:
Feb 12, 2020
Last Update Posted:
Feb 13, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maha Abdelkawy, Phd, principle investigator, Beni-Suef University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2020