Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT04735692
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Periodontal Therapy on Periodontal Bacteria
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': 'Both participants and clinicians were blinded to group and treatment assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients undergo non-surgical quadrant scaling and root planing'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '1-year', 'description': 'evaluation of changes in clinical attachment level'}]}, 'oversightModule': {'oversightHasDmc': False, '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 88 patients, aged 27 to 65 (mean age 57) 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': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least 15 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': 'NCT04735692', 'briefTitle': 'Effectiveness of Periodontal Therapy on Periodontal Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy', 'orgStudyIdInfo': {'id': '02318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Periodontitis quadrant Scaling root planing', 'description': 'Patients undergo non surgical quadrant scaling and root planing performed per quadrant', 'interventionNames': ['Other: Full mouth or quadrant SRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontitis full mouth scaling root planing', 'description': 'Patients undergo non surgical full mouth scaling and root planing', 'interventionNames': ['Other: Full mouth or quadrant SRP']}], 'interventions': [{'name': 'Full mouth or quadrant SRP', 'type': 'OTHER', 'description': 'Full mouth or quadrant SRP', 'armGroupLabels': ['Periodontitis full mouth scaling root planing', 'Periodontitis quadrant Scaling root planing']}]}, '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': 'Università degli Studi di Catania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'all collected IPD, all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}