- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995067
The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
December 9, 2023 updated by: Ali A Abdulkareem
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Baghdad, Iraq, 964
- saif mohammed T AL Mufti
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
-healthy groups/without the condition
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|
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study group
-diseased group-/with the condition (periodontitis)
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control will be compared to diseased group suffering from periodontal disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.
Time Frame: one year
|
reverse transcription real time polymerase chain reaction
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one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: one year
|
reverse transcription real time polymerase chain reaction
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2022
Primary Completion (Estimated)
January 30, 2024
Study Completion (Estimated)
January 30, 2024
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 8, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 9, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lncRNA in periodontal disease
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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