Clinical trial NCT05995067: The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
Official title: The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Periodontal Disease, AVDC Stage 3and 4
Epithelial Mesenchymal Transition
Long Noncoding RNA
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with periodontitis, and healthy periodontal tissues will be recruited at the College of Dentistry/University of Baghdad and Al Sadir specialized dental center/Al-Risafa directorate/ Ministry of Health. No age or gender restriction.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.
timeFrame: one year
Secondary outcomes:
measure: determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.
timeFrame: one year
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: saif mohammed T AL Mufti
Study officials:
References: