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CompletedNCT04267419Updated Feb 13, 2020

Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

An observational study in Oral Lichen Planus, Oral Cancer and Leukoplakia, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Beni-Suef University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Oral Lichen Planus
  • Oral Cancer
  • Leukoplakia
  • Oral Keratoses

Keywords

  • malondialdehyde
  • nitric oxide
  • salivary biomarkers
03

In context

Lichen Planus, Oral

142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 38 observational studies indexed under Lichen Planus, Oral.

Browse Lichen Planus, Oral studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

out patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy individuals with one of the following oral lesions :

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

Exclusion criteria

Exclusion Criteria:

  • subjects having systemic disorders
  • pregnant or lactating females;
  • subjects who suffered from any other mucosal lesions;
  • severe periodontal inflammation.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • healthy Control

    MDA and NO in saliva

    Diagnostic Test: salivary biomarker

  • keratosis

    MDA and NO in saliva

    Diagnostic Test: salivary biomarker

  • leukoplakia

    MDA and NO in saliva

    Diagnostic Test: salivary biomarker

  • Oral lichen Planus

    MDA and NO in saliva

    Diagnostic Test: salivary biomarker

  • oral Squamous cell carcinoma

    MDA and NO in saliva

    Diagnostic Test: salivary biomarker

Interventions

  • Diagnostic testsalivary biomarker

    MDA and NO as salivary biomarkers

06

What researchers measure

Primary outcomes

  1. Salivary MDA level in different oral lesions

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

    Time frame: 9 months

  2. Salivary NO level in different oral lesions

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

    Time frame: 9 MONTHS

07

Study locations

1 site
  • Maha Abdelkawy, Phd
    Cairo, 11553, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — all the data will shared once the work is published

Supporting information: Study protocol, Clinical study report

Time frame: once published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04267419
Responsible party
Maha Abdelkawy, Phd (principle investigator, Beni-Suef University) — Principal investigator
First posted
Feb 12, 2020
Start date
Feb 18, 2019
Primary completion
Dec 15, 2019
Completion
Dec 15, 2019
Last update
Feb 13, 2020

Study contacts

weam Elbattawy, Phd
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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