Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT04426604
Status:
UNKNOWN
Last Update Posted:
2021-08-06
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of Fluorescence-based Devices versus Visual-tactile method', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Caries Around Resin Composite Restorations']}, 'referencesModule': {'references': [{'pmid': '39762230', 'type': 'DERIVED', 'citation': 'Adly AM, Ibrahim SH, El-Zoghbi AF. Clinical validity of fluorescence-based devices versus visual-tactile method in detection of secondary caries around resin composite restorations: diagnostic accuracy study. BDJ Open. 2025 Jan 6;11(1):2. doi: 10.1038/s41405-024-00284-7.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.', 'detailedDescription': 'Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be over 18 years of age.\n* Patients should have an acceptable oral hygiene level.\n* Patients should have at least one resin composite restoration.\n\nExclusion Criteria:\n\n* Patients with a compromised medical history.\n* Patients with active severe periodontal disease.'}, 'identificationModule': {'nctId': 'NCT04426604', 'briefTitle': 'Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study', 'orgStudyIdInfo': {'id': 'AMAI-CU-2020-06-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light induced fluorescence intraoral camera', 'interventionNames': ['Diagnostic Test: Light induced fluorescence intraoral camera']}, {'type': 'EXPERIMENTAL', 'label': 'Laser-induced fluorescence device', 'interventionNames': ['Diagnostic Test: Laser-induced fluorescence device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Visual-tactile assessment method according to FDI criteria', 'interventionNames': ['Diagnostic Test: Visual-tactile assessment method according to FDI criteria']}], 'interventions': [{'name': 'Light induced fluorescence intraoral camera', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations', 'armGroupLabels': ['Light induced fluorescence intraoral camera']}, {'name': 'Laser-induced fluorescence device', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations', 'armGroupLabels': ['Laser-induced fluorescence device']}, {'name': 'Visual-tactile assessment method according to FDI criteria', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations', 'armGroupLabels': ['Visual-tactile assessment method according to FDI criteria']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': "Aya Mohamed Adly Ibrahim, Master's Degree", 'role': 'CONTACT', 'email': 'aya.mohamed@dentistry.cu.edu.eg', 'phone': '+201221528843'}, {'name': 'Shereen Hafez Ibrahim, Associate Professor (PhD)', 'role': 'CONTACT', 'email': 'shereen.hafez@dentistry.cu.edu.eg', 'phone': '+201099296591'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': "Aya Mohamed Adly Ibrahim, Master's Degree", 'role': 'CONTACT', 'email': 'aya.mohamed@dentistry.cu.edu.eg', 'phone': '+201221528843'}, {'name': 'Shereen Hafez Ibrahim, Associate Professor (PhD)', 'role': 'CONTACT', 'email': 'shereen.hafez@dentistry.cu.edu.eg', 'phone': '+201099296591'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aya Mohamed Adly', 'investigatorAffiliation': 'Cairo University'}}}}