Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT03873935
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2019-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D in Periodontal and Cardiovascular Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment level', 'timeFrame': '1 year', 'description': 'Clinical Analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.', 'detailedDescription': 'Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will finally enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least twenty teeth\n* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥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* 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': 'NCT03873935', 'briefTitle': 'Vitamin D in Periodontal and Cardiovascular Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression', 'orgStudyIdInfo': {'id': '#17-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Healthy subjects', 'interventionNames': ['Other: Evaluation of periodontal status']}, {'label': 'Periodontitis', 'description': 'Patients with periodontal disease', 'interventionNames': ['Other: Evaluation of periodontal status']}, {'label': 'Cardiovascular', 'description': 'Patients with cardiovascular disease', 'interventionNames': ['Other: Evaluation of periodontal status']}, {'label': 'Periodontitis+Cardiovascular', 'description': 'People with both cardiovascular and periodontitis', 'interventionNames': ['Other: Evaluation of periodontal status']}], 'interventions': [{'name': 'Evaluation of periodontal status', 'type': 'OTHER', 'description': 'Clinical examination', 'armGroupLabels': ['Cardiovascular', 'Control', 'Periodontitis', 'Periodontitis+Cardiovascular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Messina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Pubmed website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gaetano Isola, DDS, PhD', 'investigatorAffiliation': 'University of Messina'}}}}