Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT06882304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC TREATMENT IN YOUNG ADULTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009970', 'term': 'Orthodontics'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 368}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of white spot lesions in enamel after orthodontic treatment in young adults', 'timeFrame': 'baseline', 'description': 'to measure the prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['White Spot Lesion']}, 'referencesModule': {'references': [{'pmid': '21208070', 'type': 'BACKGROUND', 'citation': 'Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.'}, {'pmid': '25502686', 'type': 'BACKGROUND', 'citation': 'Akin M, Tezcan M, Ileri Z, Ayhan F. Incidence of white spot lesions among patients treated with self- and conventional ligation systems. Clin Oral Investig. 2015 Jul;19(6):1501-6. doi: 10.1007/s00784-014-1382-3. Epub 2014 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to measure prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients whose age between 18-30 years old consulting in the outpatient clinic.\n2. Provide informed consent.\n3. Co-operative patients approving to participate in the trial.\n4. Both sexes are included\n5. Egyptian', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients whose age between 18-30 years old consulting in the outpatient clinic.\n2. Provide informed consent.\n3. Co-operative patients approving to participate in the trial.\n4. Both sexes are included\n5. Egyptian -\n\nExclusion Criteria:\n\n1. Patients under or over this age group.\n2. Patients with other developmental defect, such as; fluorosis, amelogenesis imperfecta and syndromes associated with enamel formation defects.\n3. Patient with MIH .\n4. Refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06882304', 'briefTitle': 'PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC TREATMENT IN YOUNG ADULTS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC', 'orgStudyIdInfo': {'id': 'WSL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'orthodontic treatment', 'type': 'OTHER', 'description': 'young adult after orthodontic treatment'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ayatellah Mohamed, Master candidate', 'role': 'CONTACT', 'email': 'ayatellah.ossman@dentistry.cu.edu.eg', 'phone': '01004600321'}, {'name': 'Amir Hafez, Assistant professor', 'role': 'CONTACT', 'email': 'amir.hafez@dentistry.cu.edu.eg', 'phone': '01100001278'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ayatellah Mohamed', 'investigatorFullName': 'AYATELLAH MOHAMED OSMAN MOHAMED MOHAMED GHONIMA', 'investigatorAffiliation': 'Cairo University'}}}}