Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 6:03 AM
Study NCT ID:
NCT05995067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'gingival tissue byproduct of resective periodontal surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-09', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.', 'timeFrame': 'one year', 'description': 'reverse transcription real time polymerase chain reaction'}], 'secondaryOutcomes': [{'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', 'description': 'reverse transcription real time polymerase chain reaction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Disease, AVDC Stage 3and 4', 'Epithelial Mesenchymal Transition', 'Long Noncoding RNA']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with no history of systemic disease e.g., diabetes.\n* Both males and females will be included in the study.\n* Control group: patients fit the case definition of gingival health2, and confirmed by Histopathological inflammatory cell infiltration analysis.\n* Periodontitis group: patients fit the case definition of periodontal disease referred for periodontal flap surgery (modified Widman's flap).\n* Patients radiographically confirmed with infrabony pocket eligible for periodontal flap surgery.\n\nExclusion Criteria:\n\n* Patients not willing to participate or consent.\n* Patient taking medications that affect or modify immunity (e.g., corticosteroid), for the last 3 months.\n* Patient taking NSAIDs for the last 3 months.\n* Active smoker."}, 'identificationModule': {'nctId': 'NCT05995067', 'briefTitle': 'The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis', 'orgStudyIdInfo': {'id': 'lncRNA in periodontal disease'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': '-healthy groups/without the condition'}, {'label': 'study group', 'description': '-diseased group-/with the condition (periodontitis)', 'interventionNames': ['Other: periodontitis challenge']}], 'interventions': [{'name': 'periodontitis challenge', 'type': 'OTHER', 'description': 'control will be compared to diseased group suffering from periodontal disease.', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '964', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'saif mohammed T AL Mufti', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ali A Abdulkareem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor- department of periodontics-college of dentistry- Baghdad university', 'investigatorFullName': 'Ali A Abdulkareem', 'investigatorAffiliation': 'University of Baghdad'}}}}