Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT02221206
Status:
UNKNOWN
Last Update Posted:
2014-09-19
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root resorption', 'timeFrame': '10 months after implant insertion', 'description': 'orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mini-Screw implant anchorage', 'retraction of maxillary incisors'], 'conditions': ['Dental Dysgnathia']}, 'descriptionModule': {'briefSummary': 'The intended study is designed as a prospective randomized controlled trial (RCT), comparing and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum anchorage by retracting the maxillary incisors.', 'detailedDescription': 'The objective of the clinical study proposal will be to investigate the performance of early root resorption in order to find out if the magnitude and direction of retraction is appropriate for the retraction of maxillary incisors following the mini-screw anchorage.\n\nTherefore, the study will compare and contrast the efficacy and results of the volumetric measurement by CBCT.\n\nPatients\n\nMales or females whose diagnoses require implant anchorage treatment will be included in the study. Inclusion criteria for the study are as followings:\n\nOrthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in the CBCT Good oral hygiene and normal wound healing capacity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orthodontic indication for skeletal anchorage\n* Adequate bone quantity for a palatal implant in the CBCT\n* Good oral hygiene and normal wound healing capacity\n\nExclusion Criteria:\n\n* Patients with cheilognathopalatoschisis and other system syndromes associated with craniofacial anomalies\n* Patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous radiation therapy or chemotherapy\n* Patients with metabolic bone diseases or uncontrolled endocrine disorders\n* Alcohol or drug abuse\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02221206', 'briefTitle': 'Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors', 'orgStudyIdInfo': {'id': 'NSF81371167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'mini-screw implant anchorage-assisted retraction of maxillary incisors', 'interventionNames': ['Device: Mini-Screw implant']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'regular maximum anchorage'}], 'interventions': [{'name': 'Mini-Screw implant', 'type': 'DEVICE', 'description': 'Mini-screw implants (VectorTASTM8\\*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of Orthodontics, Hospital of Stomatology, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Mengjie Wu, MD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthodontics, Hospital of Stomatology, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mengjie Wu', 'investigatorAffiliation': 'Zhejiang University'}}}}