Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 5:06 PM
Study NCT ID:
NCT07014332
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-09', 'size': 190137, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-30T12:23', 'hasProtocol': True}, {'date': '2024-09-19', 'size': 318932, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-30T12:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alignment time to reach little irregularity index of zero', 'timeFrame': 'From recruitment to 8 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthodontic treatment', 'Ligature type', 'Steel ligature', 'Elastomeric ligature', 'Alignment time'], 'conditions': ['Malocclusion of Anterior Teeth']}, 'descriptionModule': {'briefSummary': 'To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth.', 'detailedDescription': 'Treatment time required to achieve alignment by two ligation methods will help us in future to choose a better method. The two methods study are elastomeric ligature and steel ligature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients coming for fixed orthodontic treatment requiring premolar extraction in mandibular arch.\n2. Age 12-18 years.\n3. No adjunct therapeutic intervention involving functional or orthopaedic appliances.\n4. Little's Irregularity index score of 7-9mm.\n\nExclusion Criteria:\n\n1. Patients with systemic conditions and taking medications affecting tooth movement.\n2. Lower anterior teeth that are missing, impacted or unerupted, or have fractured crown, restorations, Enamel Defects, Caries.\n3. Poor periodontal health"}, 'identificationModule': {'nctId': 'NCT07014332', 'briefTitle': 'Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Khyber College of dentistry'}, 'officialTitle': 'Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '45/ADR/KCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A received steel ligature and group B elastomeric ligature', 'interventionNames': ['Device: Steel ligature', 'Device: Elastomeric ligature']}], 'interventions': [{'name': 'Steel ligature', 'type': 'DEVICE', 'description': 'Steel ligatures that are used to ligate wire with bracket', 'armGroupLabels': ['Group A received steel ligature and group B elastomeric ligature']}, {'name': 'Elastomeric ligature', 'type': 'DEVICE', 'description': 'Elastomeric ligature that is used to ligate wire to bracket', 'armGroupLabels': ['Group A received steel ligature and group B elastomeric ligature']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Khyber College of Dentistry', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Ahsan Mehmood Shah, Fellowship', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Khyber College of dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber College of dentistry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Aatikah Javaid', 'investigatorAffiliation': 'Khyber College of dentistry'}}}}