Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-02-28 @ 2:12 PM
Study NCT ID:
NCT04270006
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2020-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2020-02-08', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in gingival inflammation', 'timeFrame': '0, 3 and 6 months', 'description': 'Gingival index (GI)'}, {'measure': 'change in pocket depth', 'timeFrame': '0, 3 and 6 months', 'description': 'Probing depth (PD)'}, {'measure': 'change in attachment level', 'timeFrame': '0, 3 and 6 months', 'description': 'Clinical attachment level (CAL)'}, {'measure': 'change in Bone level', 'timeFrame': '0 and 6 months', 'description': 'Cone beam C.T (CBCT)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis', 'SRP', 'ADSCs', 'Exosomes', 'treatment'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced periodontitis (Stage III or IV)\n* Healthy patients.\n\nExclusion Criteria:\n\n* Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.'}, 'identificationModule': {'nctId': 'NCT04270006', 'acronym': 'exosomes', 'briefTitle': 'Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effect of Adipose Derived Stem Cells Exosomes as an Adjunctive Therapy to Scaling and Root Planning in the Treatment of Periodontitis: A Human Clinical Trial', 'orgStudyIdInfo': {'id': 'FDBSUREC/21012020/ME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exosomes', 'interventionNames': ['Biological: adipose derived stem cells exosomes']}], 'interventions': [{'name': 'adipose derived stem cells exosomes', 'type': 'BIOLOGICAL', 'description': 'they are small extracellular vesicles', 'armGroupLabels': ['Exosomes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62511', 'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ebtehal Mohammed, lecturer', 'role': 'CONTACT', 'email': 'ebtehalmaawad@dent.bsu.edu.eg', 'phone': '01224336896'}], 'facility': 'Beni-Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}, {'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ebtehal Mohammed', 'role': 'CONTACT', 'email': 'ebtehalmaawad@dent.bsu.edu.eg', 'phone': '01224336896'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ebtehal Mohammed, Ph.D', 'role': 'CONTACT', 'email': 'ebtehalmaawad@dent.bsu.edu.eg,', 'phone': '01224336896'}, {'name': 'Noha Saleh, Ph.D', 'role': 'CONTACT', 'email': 'noha.saleh@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Ebtehal Mohammed, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.'}, {'name': 'Nesrine Mohammed Khairy, Associated Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University'}, {'name': 'Noha Saleh Mohammed, Associated', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.'}, {'name': 'Dina Sabry, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biochemistry, Faculty of Medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'the data will be available after at least one year', 'ipdSharing': 'YES', 'description': 'the data will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of oral medicine, periodontotlogy and oral diagnosis', 'investigatorFullName': 'Ebtehal Mohammed', 'investigatorAffiliation': 'Beni-Suef University'}}}}