Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT06510569
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-01', 'size': 481153, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-13T21:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-07-14', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Root resorption', 'timeFrame': '6 month', 'description': 'CBCT evaluation of root resorption'}], 'primaryOutcomes': [{'measure': 'Correction of lower anterior crowding', 'timeFrame': '6 months', 'description': 'according to little irregularity index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pathological Resorption of External Root']}, 'referencesModule': {'references': [{'pmid': '36437397', 'type': 'RESULT', 'citation': "Fiori A, Minervini G, Nucci L, d'Apuzzo F, Perillo L, Grassia V. Predictability of crowding resolution in clear aligner treatment. Prog Orthod. 2022 Nov 28;23(1):43. doi: 10.1186/s40510-022-00438-z."}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36437397/', 'label': 'Predictability of crowding resolution in clear aligner treatment'}]}, 'descriptionModule': {'briefSummary': 'Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.', 'detailedDescription': 'Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.\n\nGroup (B): Patients will be treated with clear aligner therapy in lower anterior crowding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .\n\nExclusion Criteria:\n\nPrevious orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.'}, 'identificationModule': {'nctId': 'NCT06510569', 'briefTitle': '3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Three-Dimensional Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ORTHO-109-2-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clear aligner therapy', 'description': 'U lab aligners', 'interventionNames': ['Device: U lab aligners']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed orthodontic treatment', 'description': 'Oromo bracket', 'interventionNames': ['Device: oramco bracket']}], 'interventions': [{'name': 'U lab aligners', 'type': 'DEVICE', 'description': 'Aligner group change the aligner every 10 days', 'armGroupLabels': ['Clear aligner therapy']}, {'name': 'oramco bracket', 'type': 'DEVICE', 'description': 'changing orthodontic wire every one month', 'armGroupLabels': ['Fixed orthodontic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al Azhar Universty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '002', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Haidy Fekry', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'samir A ibrahim, proffesor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al azhar universty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haidy Fekry', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'dentist', 'investigatorFullName': 'Haidy Fekry', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}