Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04330794
Status:
UNKNOWN
Last Update Posted:
2020-04-02
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the NMFACT Caries Index
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004245', 'term': 'DMF Index'}], 'ancestors': [{'id': 'D003753', 'term': 'Dental Health Surveys'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the accuracy of NMFACT index in describe the oral health condition', 'timeFrame': '3months', 'description': 'finding from the group will be compared to clinical examination by different accessors .the accurate detailed description of the oral health condition will assessed statistically'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': "the NMFACT is a new caries index to overcome the drawbacks of DMF cries index the ''N'' is for non carious lesion, the ''M''for missed teeth,the ''F''for filled teeth,the''C''for carious teeth,the ''A''for alignment and the ''T''for dental trauma.\n\neach problem will be scored from 0(normal).", 'detailedDescription': 'the new caries index will be used to record the dental problem . the validation will be recorded against the gold standard DMF index'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient suffering form dental problem\n\nExclusion Criteria:\n\n* edentulous patient children adolescents'}, 'identificationModule': {'nctId': 'NCT04330794', 'briefTitle': 'the NMFACT Caries Index', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'the NMFACT Anew Caries Index', 'orgStudyIdInfo': {'id': '23456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMFACT', 'description': 'record the caries index using the NMFACT chart', 'interventionNames': ['Other: NMFACT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DMF index', 'description': 'record the caries index using the DMF chart', 'interventionNames': ['Other: DMF index']}], 'interventions': [{'name': 'NMFACT', 'type': 'OTHER', 'otherNames': ['NMFACT chart'], 'description': 'caries index', 'armGroupLabels': ['NMFACT']}, {'name': 'DMF index', 'type': 'OTHER', 'otherNames': ['DMF chart'], 'description': 'caries index chart to collect data about decayed missed filled teeth', 'armGroupLabels': ['DMF index']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Dina mounir elkady', 'investigatorAffiliation': 'Cairo University'}}}}