Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-10 @ 12:05 PM
Study NCT ID:
NCT03342066
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'bacteria isolated from saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-10', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducability "degree of matching between cariogram and cambra', 'timeFrame': 'one day', 'description': 'reproducability of cariogram and cambra'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study', 'detailedDescription': "A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride.\n\nThus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of both sex ,age from 18-40 with different oral hygiene and different dental condition but with good periodontal condition and no multiple extraction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be in range of 18-40 years old. Patient should have good periodontal health\n\nExclusion Criteria:\n\n* Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction'}, 'identificationModule': {'nctId': 'NCT03342066', 'briefTitle': 'Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form on Clinician Decision: Observational Study', 'orgStudyIdInfo': {'id': 'gsda.1986'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Cariogram', 'interventionNames': ['Diagnostic Test: reproducability of caries risk assessment']}, {'label': 'B', 'description': 'CAMBRA', 'interventionNames': ['Diagnostic Test: reproducability of caries risk assessment']}], 'interventions': [{'name': 'reproducability of caries risk assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'reproducability of caries risk assessment CAMBRA verses cariogram', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0220', 'city': 'Cairo', 'state': 'Manial', 'country': 'Egypt', 'facility': 'Cairo Univeristy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed farid, prof.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor, Conservative Dentistry Department, Faculty of dentistry, Cairo University, Egypt.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist', 'investigatorFullName': 'Aya Gamal ashour', 'investigatorAffiliation': 'Cairo University'}}}}