Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06023433
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sealed envelopes'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'miRNAs expression', 'timeFrame': '6 weeks', 'description': 'miRNAs expression in the gingival crevicular fluid by PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Tooth Movement']}, 'referencesModule': {'references': [{'pmid': '39736760', 'type': 'DERIVED', 'citation': 'Polizzi A, Alibrandi A, Lo Giudice A, Distefano A, Orlando L, Analazi AM, Pizzo G, Volti GL, Isola G. Impact of periodontal microRNAs associated with alveolar bone remodeling during orthodontic tooth movement: a randomized clinical trial. J Transl Med. 2024 Dec 30;22(1):1155. doi: 10.1186/s12967-024-05933-x.'}]}, 'descriptionModule': {'briefSummary': 'A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars.\n\nSamples of gingival crevicular fluid on the mesial and distal side of the canines to be examined will be performed during the baseline and during various follow-ups.', 'detailedDescription': 'A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars.\n\nOrthodontic tooth movement induces bone remodeling by various signaling pathways. The variations in miRNAs expression and their impact in inflammation and osteoclastogenesis during the various stages of orthodontic tooth movements is not fully understood.\n\n58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes have been enrolled for this split-mouth study: the canines to be distalized on the extractive site are considered as the test group, the controlateral canines (on the side without first premolar extraction) areconsidered as normal controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with excellent oral hygiene throughout the study period,\n* patients requiring asymmetrical maxillary first premolar extraction so monolateral canine retraction will be performed as a part of the treatment,\n* patients available to come back at the clinic at the times of sample collection.\n\nExclusion Criteria:\n\n* poor oral hygiene and/or bleeding on probing,\n* use medications, steroids or other anti-inflammatory medications,\n* systemic health problems or smoking.'}, 'identificationModule': {'nctId': 'NCT06023433', 'briefTitle': 'Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement: a Split Mouth Study', 'orgStudyIdInfo': {'id': '121-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Canines to be distalized', 'description': 'The canines need distalization after orthodontic upper first premolar asymmetrical extractions.', 'interventionNames': ['Device: Elastomeric powerchain']}, {'type': 'NO_INTERVENTION', 'label': 'Controlateral canines', 'description': "The controlateral canines don't need distalization since the adjacent first premolars are not extracted."}], 'interventions': [{'name': 'Elastomeric powerchain', 'type': 'DEVICE', 'description': 'Canine distalization by engaging the elastomeric power chains onto the canine brackets.', 'armGroupLabels': ['Canines to be distalized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'country': 'Italy', 'facility': 'AOU Policlinico G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Catania'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'accessCriteria': 'Pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}