Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-28 @ 3:21 PM
Study NCT ID:
NCT03650634
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014096', 'term': 'Tooth, Supernumerary'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of supernumerary teeth', 'timeFrame': '6 months', 'description': 'Measuring device: clinical examination. Measuring unit : binary (yes or/ no ).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['supernumerary tooth', 'hyperdontia', 'mesiodens', 'paramolar'], 'conditions': ['Supernumerary Teeth']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.", 'detailedDescription': '* Clinical examination will be done for participants fulfilling the inclusion criteria after obtaining an informed consent from parents for acceptance of participation in the study after explaining the purpose of the study and the measures that will be held to the child.\n* A custom made examination chart (Appendix 1) will be filled out, during face to face interview with the child and/or his parents, including: date, name, age, gender, address, medical history and previous dental treatment followed by clinical examination to detect the presence of supernumerary teeth.\n* The presence of supernumerary teeth and its type and location will be recorded in the examination chart.\n* Each child with supernumerary teeth will be given a letter, translated into Arabic, outlining his dental status to inform the parents about the condition and the need for treatment\n\nExamination chart (Appendix 1 ):\n\nDate :...................................................................\n\nPersonal information:\n\nName............................................. Age..........................................\n\nGender :.......................................... Address : ................................\n\nPhone number : .................................................. Medical history: ......................................................... ..................................................................................\n\nPrevious dental history: ...........................................\n\n......................................................................................\n\nClinical examination :\n\nSupernumerary teeth: presence / absence Location : ........................................... Type :..................................................'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants will be selected from the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University according to the eligibility criteria.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive patient and parent acceptance for participation in the study.\n* Patients who are medically free from any systemic disease.\n* Children aged from 6 to 15 years old.\n* Both sexes will be included.\n\nExclusion Criteria:\n\n* Uncooperative children.\n* Handicapped children.\n* Children who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03650634', 'briefTitle': 'Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old: a Cross Sectional Study', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-08-16'}}, 'contactsLocationsModule': {'locations': [{'zip': '22412', 'city': 'Cairo', 'state': 'Manial', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Randa Youssef, Ass.prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Rasha Hatem, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student in Cairo University ( principal Investigator)', 'investigatorFullName': 'Riham Ahmed El-Halafawey Anwar Emam', 'investigatorAffiliation': 'Cairo University'}}}}