Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT05174494
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Periodontal Treatment on NT-proBNP Levels
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Though sealed envelopes both clinicians and patients were masked to the selected treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Clinical Attachment Level', 'timeFrame': '6-months', 'description': 'Change of periodontal Clinical Attachment Level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis', 'serum markers', 'CRP', 'NT-proBNP'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Intensive scaling and root planing (SRP) treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.\n\nThe null hypothesis to invalidate was that there were no variations, in relation to clinical and serum CRP and NT-proBNP.', 'detailedDescription': "This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.\n\nSubjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP (test group) or oral hygiene treatment (control group)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good condition of general health\n* a minimum of 2 teeth for each quadrant with\n* Pocket Depth (PD) ranging from 4-6 mm\n* no involvement of the furcation\n* a minimum of a six teeth per quadrant, respectively\n\nExclusion Criteria:\n\n* periodontal therapy during the last 12 months\n* assumption of antibiotics during the last 6 months\n* pregnancy\n* any systemic condition which might affect the effects of the study treatment\n* previous or current radiation or immunosuppressive therapies\n* use of mouthwash containing antimicrobials during the previous 3 months\n* no use of hormonal contraceptives\n* medication by anti-inflammatory and immunosuppressive drugs\n* previous history of hard drinking\n* smoking\n* class II and III tooth mobility'}, 'identificationModule': {'nctId': 'NCT05174494', 'briefTitle': 'Impact of Periodontal Treatment on NT-proBNP Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels', 'orgStudyIdInfo': {'id': '121/20/PO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Full mouth non surgical periodontal treatment', 'description': 'Each selected subject underwent to full mouth SRP.', 'interventionNames': ['Diagnostic Test: Evaluation of serum CRP and NT-proBNP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Each selected subject underwent full mouth traditional oral hygiene.', 'interventionNames': ['Diagnostic Test: Evaluation of serum CRP and NT-proBNP']}], 'interventions': [{'name': 'Evaluation of serum CRP and NT-proBNP', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP', 'armGroupLabels': ['Control', 'Full mouth non surgical periodontal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'University of Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1-year', 'ipdSharing': 'YES', 'description': 'Publish study results and IDP sharing plan', 'accessCriteria': 'Pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher, Dr.', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}