Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Oral Cancer Clinical Trial

Official title:

Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267419
• Other study ID #: FDBSUREC/17022019/AM
• Status: Completed
• Start date: February 18, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keratosis
• Leukoplakia
• Leukoplakia, Oral
• Lichen Planus
• Lichen Planus, Oral
• Mouth Neoplasms
• Oral Cancer
• Oral Keratoses
• Oral Lichen Planus

Intervention

Diagnostic Test:
• salivary biomarker
MDA and NO as salivary biomarkers

Locations

Country	Name	City	State
Egypt	Maha Abdelkawy, Phd	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary MDA level in different oral lesions	The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.	9 months
Primary	Salivary NO level in different oral lesions	The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.	9 MONTHS