Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-04-18 @ 1:56 PM
Study NCT ID:
NCT04382261
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2020-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment level', 'timeFrame': '180 days', 'description': 'Analysis of reduction of clinical attachment level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of Periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth scaling or quadrant scaling', 'detailedDescription': "This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 102 patients, , aged 27 to 65 (mean age 44.2) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. good condition of general health,\n2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,\n3. no involvement of the furcation,\n4. a minimum of a six teeth per quadrant, respectively.\n\nExclusion Criteria:\n\n1. periodontal therapy during the last 12 months,\n2. assumption of antibiotics during the last 6 months,\n3. pregnancy,\n4. any systemic condition which might affect the effects of the study treatment,\n5. previous or current radiation or immunosuppressive therapies,\n6. use of mouthwash containing antimicrobials during the previous 3 months,\n7. no use of hormonal contraceptives,\n8. medication by anti-inflammatory and immunosuppressive drugs,\n9. previous history of hard-drinking,\n10. smoking,\n11. class II and III tooth mobility.'}, 'identificationModule': {'nctId': 'NCT04382261', 'briefTitle': 'Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study', 'orgStudyIdInfo': {'id': '20-2018-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Periodontitis quadrant', 'description': 'Patients undergo non surgical quadrant scaling and root planing', 'interventionNames': ['Procedure: Scaling and root planing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontitis full mouth', 'description': 'Patients undergo non surgical full mouth scaling and root planing', 'interventionNames': ['Procedure: Scaling and root planing']}], 'interventions': [{'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'Full mouth or quadrant SRP', 'armGroupLabels': ['Periodontitis full mouth', 'Periodontitis quadrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98100', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Messina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'Sharing inflammatory results', 'accessCriteria': 'University website and pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Gaetano Isola, DDS, PhD', 'investigatorAffiliation': 'University of Messina'}}}}