Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
Study NCT ID:
NCT04143568
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2019-10-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Progenitor Cells Levels in Periodontal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-26', 'studyFirstSubmitDate': '2019-10-26', 'studyFirstSubmitQcDate': '2019-10-26', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of endothelial progenitor cells level', 'timeFrame': '1 year', 'description': 'Changes of endothelial progenitor cells level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Disease']}, 'descriptionModule': {'briefSummary': 'Recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically, CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.', 'detailedDescription': 'The aim of the present study was to investigate the association between endothelial progenitor cells (EPCs) levels subtype (CD133+/KDR+), in patients with periodontitis.\n\nFurthermore, the objective was to determine if the periodontal status influenced CD133+/KDR+ levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '79 healthy subjects, 88 patients with CP. Lipid profile and levels of CD133 and C-reactive protein (CRP) were evaluated.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least 16 teeth\n* CP with a minimum of 40% of sites with a clinical attachment level (CAL)\n\n ≥2mm and probing depth (PD) ≥4mm;\n* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs\n* Presence of ≥40% sites with bleeding on probing (BOP)\n\nExclusion Criteria:\n\n* Intake of contraceptives\n\n * Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study\n * Status of pregnancy or lactation\n * Previous history of excessive drinking\n * Allergy to local anaesthetic\n * Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.'}, 'identificationModule': {'nctId': 'NCT04143568', 'briefTitle': 'Circulating Progenitor Cells Levels in Periodontal Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Analysis of Circulating Progenitor Cells Levels in Periodontal Disease Patients', 'orgStudyIdInfo': {'id': '106-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}, {'label': 'Periodontitis', 'description': 'Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease', 'armGroupLabels': ['Control', 'Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '5 years', 'ipdSharing': 'YES', 'description': 'all collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'IRB university of messina'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Assistant Professor', 'investigatorFullName': 'Gaetano Isola, DDS, PhD', 'investigatorAffiliation': 'University of Messina'}}}}