Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

Completed

• Conditions: Potentially Malignant Lesions; Oral Lichen Planus; Leukoplakia, Oral
• Interventions: Diagnostic Test: Real-time Polymerase Chain Reaction technique

• Registration Number: NCT05730855
• Lead Sponsor: Fayoum University

Brief Summary

The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2022-12-24
• Study Completion: 2023-01-23
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• participants will be divided into 3 groups:

Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria

• Subjects taking any drugs inducing any changes that could affect the salivary flow.
• Pregnant females.
• Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
• Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	Real-time Polymerase Chain Reaction technique	-
Leukoplakia	Real-time Polymerase Chain Reaction technique	-
Oral Lichen Planus	Real-time Polymerase Chain Reaction technique	-

Primary Outcome Measures

Name	Time	Method
salivary expression of lncDQ786243 in OLP, Leukoplakia, control	2 months

Secondary Outcome Measures

Name	Time	Method
salivary expression of miRNA146a in OLP, Leukoplakia, control	2 months

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt