Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-28 @ 1:15 AM
Study NCT ID:
NCT03923192
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held ."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dental caries', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'hidden proximal caries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Dental Caries']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the Clinical performance of the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 18 to 40 years.\n* No gender restriction.\n* Patients should have an acceptable oral hygiene level.\n* Patients must have at least one posterior proximal caries\n\nExclusion Criteria:\n\n* Patients with a compromised medical history.\n* Severe or active periodontal disease.\n* Heavy bruxism or a traumatic occlusion.\n* Acute or chronic dental infection.\n* Pregnant or breastfeeding women.\n* Patients with posterior restorations on molars or premolars'}, 'identificationModule': {'nctId': 'NCT03923192', 'briefTitle': 'Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Validity of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions: Diagnostic Accuracy Study.', 'orgStudyIdInfo': {'id': '2411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ICDAS II', 'description': 'Visual tactile examination based on ICDASII scoring system', 'interventionNames': ['Device: Vistacam', 'Radiation: Bitewing radiograph']}], 'interventions': [{'name': 'Vistacam', 'type': 'DEVICE', 'description': 'device for early proximal caries detection', 'armGroupLabels': ['ICDAS II']}, {'name': 'Bitewing radiograph', 'type': 'RADIATION', 'description': 'radiograph for proximal caries detection', 'armGroupLabels': ['ICDAS II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223453', 'city': 'Cairo', 'state': 'Other', 'country': 'Egypt', 'facility': 'The British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Amr Abdel Fattah Mahmoud Edrees', 'investigatorAffiliation': 'Cairo University'}}}}