Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT06600360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-28
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Teledentistry for Diagnosis and Treatment Need in Dental Caries Detection Versus Clinical Examination on a Group of Egyptian Children: A Diagnostic Accuracy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teledentistry for dental caries detection', 'timeFrame': '3 months', 'description': 'By measuring the accuracy of mobile photographic method of teledentistry for dental caries detection'}], 'secondaryOutcomes': [{'measure': 'Clinical dental caries examination', 'timeFrame': '3 months', 'description': 'By measuring the accuracy of clinical dental caries examination'}, {'measure': 'Reliability of treatment needs', 'timeFrame': '3 months', 'description': 'By measuring the accuracy of teledentistry for treatment need'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teledentistry in diagnosis and treatment planning', 'Teledentistry'], 'conditions': ['Teledentistry']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the accuracy of teledentistry for diagnosis and treatment need in dental caries detection versus clinical examination on a group of Egyptian children.', 'detailedDescription': 'The objective of this study is to assess the precision of using the mobile photographic method of teledentistry for dental caries diagnosis and treatment need of pediatric Egyptian children. This will be assessed by measuring the diagnostic accuracy of the mobile photographic method versus direct clinical oral examination for the same group of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are Egyptian children with dental caries attending the diagnostic center at the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian pediatric patients aged 4 to 12 years with a chief complaint of dental caries with or without pain.\n* Both genders are included.\n\nExclusion Criteria:\n\n* Egyptian pediatric patients with systemic conditions that will affect their treatment needs.\n* Refusal of participation.\n* Refusal to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT06600360', 'briefTitle': 'Accuracy of Teledentistry for Diagnosis and Treatment Need in Dental Caries Detection Versus Clinical Examination on a Group of Egyptian Children: A Diagnostic Accuracy Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Accuracy of Teledentistry for Diagnosis and Treatment Need in Dental Caries Detection Versus Clinical Examination on a Group of Egyptian Children: A Diagnostic Accuracy Study', 'orgStudyIdInfo': {'id': 'TELE24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Teledentistry', 'type': 'OTHER', 'description': 'Measuring the accuracy of the mobile photographic method of teledentistry for diagnosis and treatment need in dental caries detection'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pancee A Wafi, BSc', 'role': 'CONTACT', 'email': 'pancee.adel@dentistry.cu.edu.eg', 'phone': '+20 01006150228', 'phoneExt': '002'}, {'name': 'Perihan A Wafi, BSc', 'role': 'CONTACT', 'email': 'perihan.adel@dentistry.cu.edu.eg', 'phone': '+20 01006150247', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant at Faculty of Dentistry', 'investigatorFullName': 'Pancee Adel Abdel Aziz Wafi', 'investigatorAffiliation': 'NewGiza University'}}}}