Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedFebruary 13, 2020
February 1, 2020
10 months
February 9, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
healthy Control
MDA and NO in saliva
keratosis
MDA and NO in saliva
leukoplakia
MDA and NO in saliva
Oral lichen Planus
MDA and NO in saliva
oral Squamous cell carcinoma
MDA and NO in saliva
Interventions
MDA and NO as salivary biomarkers
Eligibility Criteria
out patients
You may qualify if:
- healthy individuals with one of the following oral lesions :
- keratosis
- Oral lichen planus
- oral squamous cell carcinoma
- oral leukoplakia
You may not qualify if:
- subjects having systemic disorders
- pregnant or lactating females;
- subjects who suffered from any other mucosal lesions;
- severe periodontal inflammation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maha Abdelkawy, Phd
Cairo, 11553, Egypt
Biospecimen
saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
weam Elbattawy, Phd
Cairo University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
February 9, 2020
First Posted
February 12, 2020
Study Start
February 18, 2019
Primary Completion
December 15, 2019
Study Completion
December 15, 2019
Last Updated
February 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- once published
all the data will shared once the work is published