Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

NCT ID: NCT04267419

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-12-15

Brief Summary

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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

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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

Conditions

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Oral Lichen Planus Oral Cancer Leukoplakia Oral Keratoses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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healthy Control

MDA and NO in saliva

salivary biomarker

Intervention Type DIAGNOSTIC_TEST

MDA and NO as salivary biomarkers

keratosis

MDA and NO in saliva

salivary biomarker

Intervention Type DIAGNOSTIC_TEST

MDA and NO as salivary biomarkers

leukoplakia

MDA and NO in saliva

salivary biomarker

Intervention Type DIAGNOSTIC_TEST

MDA and NO as salivary biomarkers

Oral lichen Planus

MDA and NO in saliva

salivary biomarker

Intervention Type DIAGNOSTIC_TEST

MDA and NO as salivary biomarkers

oral Squamous cell carcinoma

MDA and NO in saliva

salivary biomarker

Intervention Type DIAGNOSTIC_TEST

MDA and NO as salivary biomarkers

Interventions

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salivary biomarker

MDA and NO as salivary biomarkers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Maha Abdelkawy, Phd

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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weam Elbattawy, Phd

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Maha Abdelkawy, Phd

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDBSUREC/17022019/AM

Identifier Type: -

Identifier Source: org_study_id

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