Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 10:40 AM
Study NCT ID:
NCT05127356
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'Immediate (cross-sectional)', 'description': 'Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Caries; Initial']}, 'descriptionModule': {'briefSummary': "There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.", 'detailedDescription': 'This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non cavitated incipient carious white spot lesions', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non cavitated white spot lesions.\n* Patient compliance\n\nExclusion Criteria:\n\n* Cavitated lesions.\n* Medically compromised patients.\n* Enrollment in another clinical trials.'}, 'identificationModule': {'nctId': 'NCT05127356', 'briefTitle': 'Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation', 'orgStudyIdInfo': {'id': 'Diagnodent'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laser fluorescence', 'description': 'DIAGNOdent is a laser fluorescence device that detects and quantify stages of development of incipient carious lesions\n\n0-4 healthy tooth structure; 5-10 Outer half enamel caries; 11-20 Inner half enamel caries; 21+ Dentin caries', 'interventionNames': ['Device: DIAGNOdent']}, {'label': 'Visual examination', 'description': 'ICDAS II\n\nCode 0: Sound tooth surface; Code 1: First visual change in enamel; Code 2:Distinct visual change in enamel when viewed wet; Code 3: Localized enamel breakdown due to caries with no visible dentin; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown; Code 5: Distinct cavity with visible dentin; Code 6: Extensive distinct cavity with visible dentin.', 'interventionNames': ['Diagnostic Test: ICDAS II']}], 'interventions': [{'name': 'DIAGNOdent', 'type': 'DEVICE', 'description': 'Laser fluorescence device', 'armGroupLabels': ['Laser fluorescence']}, {'name': 'ICDAS II', 'type': 'DIAGNOSTIC_TEST', 'description': 'International Caries Detection and Assessment System (ICDAS II)', 'armGroupLabels': ['Visual examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'El Manial', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Omar O Shaalan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Conservative Dentistry Department, Faculty of Dentistry', 'investigatorFullName': 'Omar Osama Shaalan', 'investigatorAffiliation': 'Cairo University'}}}}