Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 11:06 AM
Study NCT ID:
NCT06382935
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Non-surgical Periodontal Treatment of miRNome
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sealed envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2024-04-20', 'studyFirstSubmitQcDate': '2024-04-20', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing Pocket Depth', 'timeFrame': '6-months', 'description': 'Reduction in Probing Pocket Depth after treatnebt'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid', 'detailedDescription': 'A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment in subjects with periodontitis.\n\n60 patients: 30 with periodontitis and 30 healthy controls. All the patients are assessed for clinical, periodontal, blood following of minimally invasive approach MINST or Q-SI (quadrantwise).\n\nMeasurements are taken before and after initial periodontal treatment in the periodontal subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Periodontitis\n\nExclusion Criteria:\n\n* Periodontal treatment\n* Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06382935', 'briefTitle': 'Impact of Non-surgical Periodontal Treatment of miRNome', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Effects of Minimally Non-surgical Periodontal Treatment Versus Quadrantwise Subgingival Instrumentations on miRNome in Gingival Tissues', 'orgStudyIdInfo': {'id': '34-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MINST non surgical periodontal treatment', 'description': 'Periodontitis patients treated by means of MINST. Patients were treated with non-surgical MINST periodontal treatment in a single session.', 'interventionNames': ['Other: Probin Pocket Depth reduction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Q-SI non surgical periodontal treatment', 'description': 'Periodontitis patients treated by means of Q-SI. Patients were treated with non-surgical quadrantwise periodontal treatment in 4 sessions, 1 session per week.', 'interventionNames': ['Other: Probin Pocket Depth reduction']}], 'interventions': [{'name': 'Probin Pocket Depth reduction', 'type': 'OTHER', 'description': 'Probin Pocket Depth reduction in millimetres before and after treatment', 'armGroupLabels': ['MINST non surgical periodontal treatment', 'Q-SI non surgical periodontal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaetano Isola, DDS', 'role': 'CONTACT', 'email': 'gaetano.isola@unict.it', 'phone': '0953785652'}], 'facility': 'AOU Policlinico G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Gaetano Isola', 'role': 'CONTACT', 'email': 'gaetano.isola@unict.it', 'phone': '0953785652'}, {'name': 'Rosalia Leonardi', 'role': 'CONTACT', 'email': 'rleonardi@unict.it', 'phone': '0953785652'}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Catania'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1-year', 'ipdSharing': 'YES', 'description': 'Study results', 'accessCriteria': 'Pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}