The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis

Epithelial Mesenchymal Transition Clinical Trial

Official title:

The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05995067
• Other study ID #: lncRNA in periodontal disease
• Status: Active, not recruiting
• Start date: February 14, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues. It is characterized by a progressive loss of epithelial attachment and resorption of alveolar bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like and may be involved in the process of periodontal inflammation either completely or partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA dysregulation plays key roles in human diseases, including cancer, by modulating the epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have created a gap in the knowledge.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with no history of systemic disease e.g., diabetes.
• Both males and females will be included in the study.
• Control group: patients fit the case definition of gingival health2, and confirmed by Histopathological inflammatory cell infiltration analysis.
• Periodontitis group: patients fit the case definition of periodontal disease referred for periodontal flap surgery (modified Widman's flap).
• Patients radiographically confirmed with infrabony pocket eligible for periodontal flap surgery.

Exclusion Criteria:

• Patients not willing to participate or consent.
• Patient taking medications that affect or modify immunity (e.g., corticosteroid), for the last 3 months.
• Patient taking NSAIDs for the last 3 months.
• Active smoker.

Related Conditions & MeSH terms

• Epithelial Mesenchymal Transition
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• periodontitis challenge
control will be compared to diseased group suffering from periodontal disease.

Locations

Country	Name	City	State
Iraq	saif mohammed T AL Mufti	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Ali A Abdulkareem

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.	reverse transcription real time polymerase chain reaction	one year
Secondary	determine the expression of EMT-related genes (E-cadherin, Vimentin, ß-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.	reverse transcription real time polymerase chain reaction	one year