Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:32 AM
Study NCT ID:
NCT07367451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Propolis Flavonoids on TLR4 Signaling and Inflammation in Human PDLSCs In Vitro
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-18', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLR4 expression', 'timeFrame': '48 hours', 'description': 'To evaluate the expression of TLR4 in PDLSCs after treatment with propolis flavonoid extract.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TLR4', 'flavonoid-rich propolis', 'Periodontal ligament', 'stem cells'], 'conditions': ['Inflammatory Cytokine Expression']}, 'descriptionModule': {'briefSummary': 'This in-vitro study evaluated the effects of a flavonoid-rich propolis extract on Toll-like receptor 4 (TLR4) signaling and inflammatory cytokine expression in human periodontal ligament stem cells (PDLSCs). PDLSCs were treated with propolis flavonoids under baseline conditions and following lipopolysaccharide (LPS)-induced inflammation, with untreated cells serving as controls. TLR4 gene expression was analyzed using PCR, while levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) were quantified by ELISA. Cell viability and cytotoxicity at different extract concentrations were assessed using the MTT assay. The study aimed to determine the immunomodulatory and cytocompatible potential of propolis flavonoids in regulating inflammatory responses in PDLSCs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'in vitro study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invitro study on Human Periodontal Ligament Stem Cells\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT07367451', 'briefTitle': 'Effects of Propolis Flavonoids on TLR4 Signaling and Inflammation in Human PDLSCs In Vitro', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Propolis-Derived Flavonoid Extract on TLR4 Signaling and Inflammatory Cytokine Expression in Human Periodontal Ligament Stem Cells (PDLSCs): An In-Vitro Study', 'orgStudyIdInfo': {'id': '12/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated PDLSCs, and adding Flavonoid extract from propolis', 'interventionNames': ['Drug: Flavonoid extract from propolis']}, {'label': 'Isolated PDLSCs, no material added', 'interventionNames': ['Other: no medication added']}], 'interventions': [{'name': 'Flavonoid extract from propolis', 'type': 'DRUG', 'description': 'Preparation of Propolis Flavonoid Extract\n\nConcentrations for testing:\n\n5 µg/mL 10 µg/mL 20 µg/mL', 'armGroupLabels': ['Isolated PDLSCs, and adding Flavonoid extract from propolis']}, {'name': 'no medication added', 'type': 'OTHER', 'description': 'No medication will be added to the second group', 'armGroupLabels': ['Isolated PDLSCs, no material added']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Ghada Adayil', 'investigatorAffiliation': 'Cairo University'}}}}