Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-04 @ 3:40 PM
Study NCT ID:
NCT06416904
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-12', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-05-12', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of anchorage loss of the maxillary first molars', 'timeFrame': '6 months from the start of the canine retraction', 'description': 'After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models'}], 'secondaryOutcomes': [{'measure': 'Tipping of the maxillary first molar.', 'timeFrame': '6 months from the start of the canine retraction', 'description': 'the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph'}, {'measure': 'Maxillary incisors inclination', 'timeFrame': '6 months from the start of the canine retraction', 'description': 'The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion', 'detailedDescription': 'The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.\n\nAfter leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.\n\n* In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.\n* In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws\n\nLastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'female patients 15-25 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-pubertal female patients.\n* Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.\n* Full permanent dentition (not necessitating third molars).\n* Good oral hygiene.\n\nExclusion Criteria:\n\n* Medically compromised patients.\n* Active periodontal disease or obvious bone loss in the maxillary arch.\n* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).\n* Smoking or any systemic diseases.\n* Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement\n* Previous orthodontic treatment.\n* Missing teeth.'}, 'identificationModule': {'nctId': 'NCT06416904', 'briefTitle': 'Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ORTH3-3-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arch wire stopper mesial to the maxillary first molar group', 'description': 'In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars.', 'interventionNames': ['Device: archwire stopper mesial to the maxillary first molar group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'maxillary first molar indirectly anchored to the inter-radicular mini-screw group', 'description': 'In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.', 'interventionNames': ['Device: inter-radicular mini-screw']}], 'interventions': [{'name': 'archwire stopper mesial to the maxillary first molar group', 'type': 'DEVICE', 'description': 'canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.', 'armGroupLabels': ['arch wire stopper mesial to the maxillary first molar group']}, {'name': 'inter-radicular mini-screw', 'type': 'DEVICE', 'description': 'canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.', 'armGroupLabels': ['maxillary first molar indirectly anchored to the inter-radicular mini-screw group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mennatallah Moamen, BDS', 'role': 'CONTACT', 'email': 'mennatallah.moamen@dentistry.cu.edu.eg', 'phone': '+201018509275'}, {'name': 'Mennatallah Moamen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mennatallah Ali', 'role': 'CONTACT', 'email': 'mennatallah.moamen@dentistry.cu.edu.eg', 'phone': '01018509275'}], 'overallOfficials': [{'name': 'Mennatallah Ali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist', 'investigatorFullName': 'Mennatallah Moamen Mohamed Mohamed Ali', 'investigatorAffiliation': 'Cairo University'}}}}