Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 6:37 PM
Study NCT ID:
NCT04564950
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Periodontitis and Coronary Heart Disease on Galectin-3
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Clinical Attachment Level (mm)', 'timeFrame': '1-year', 'description': 'Measurment of changes in Clinical Attachment Level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels', 'detailedDescription': 'Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38) were enrolled in the present study. The analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including Endothelin-1 (ET-1) and for serum and salivary Galectin-3 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38)', '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* 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': 'NCT04564950', 'briefTitle': 'Influence of Periodontitis and Coronary Heart Disease on Galectin-3', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Influence of Periodontitis and Coronary Heart Disease on Galectin-3 in Serum and Saliva', 'orgStudyIdInfo': {'id': '18-16-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease', 'interventionNames': ['Other: Observation of serum and salivary Galectin-3 levels']}, {'label': 'Periodontitis', 'description': 'Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease', 'interventionNames': ['Other: Observation of serum and salivary Galectin-3 levels']}, {'label': 'Coronary heart disease', 'description': 'Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease', 'interventionNames': ['Other: Observation of serum and salivary Galectin-3 levels']}, {'label': 'Coronary heart disease + periodontitis', 'description': 'Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease', 'interventionNames': ['Other: Observation of serum and salivary Galectin-3 levels']}], 'interventions': [{'name': 'Observation of serum and salivary Galectin-3 levels', 'type': 'OTHER', 'description': 'Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices', 'armGroupLabels': ['Control', 'Coronary heart disease', 'Coronary heart disease + periodontitis', 'Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98100', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1-year', 'ipdSharing': 'YES', 'description': 'all collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'Official 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'}}}}