Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04382105
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Saliva IL-6 Levels and Periodontitis
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment Level', 'timeFrame': '1-year', 'description': 'evaluation 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 salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels', 'detailedDescription': 'Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary P.Gingivalis antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).', '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': 'NCT04382105', 'briefTitle': 'Evaluation of Saliva IL-6 Levels and Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Association Between Salivary IL-6 and Extent of Periodontitis', 'orgStudyIdInfo': {'id': '11-1818'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'observation of salivary IL-6 levels', 'interventionNames': ['Other: Observation of salivary IL-6 levels']}, {'label': 'Periodontitis', 'description': 'observation of salivary IL-6 levels', 'interventionNames': ['Other: Observation of salivary IL-6 levels']}], 'interventions': [{'name': 'Observation of salivary IL-6 levels', 'type': 'OTHER', 'description': 'Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease', 'armGroupLabels': ['Control', 'Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98100', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Giovanni Matarese', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Messina'}]}, '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': 'Researcher', 'investigatorFullName': 'Gaetano Isola, DDS, PhD', 'investigatorAffiliation': 'University of Messina'}}}}