Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT04124718
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005838', 'term': 'Genotype'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA for genetic analysis was isolated from buccal epithelial cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'past caries experience', 'timeFrame': '3 weeks', 'description': 'Each tooth will be examined and recorded as decayed, missing, or filled'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': '3 weeks', 'description': 'The plaque amount is scored by using Silness\\&Löe Plaque Index plaque index PI\\<1.0 healthy PI 1.1-2.0 mild PI\\>2 high plaque'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caries experience, VDR, TFIP11, enviromental risk factor'], 'conditions': ['Low Caries Experience', 'High Caries Experience']}, 'referencesModule': {'references': [{'pmid': '27472568', 'type': 'BACKGROUND', 'citation': 'Cogulu D, Onay H, Ozdemir Y, Aslan GI, Ozkinay F, Eronat C. The Role of Vitamin D Receptor Polymorphisms on Dental Caries. J Clin Pediatr Dent. 2016;40(3):211-4. doi: 10.17796/1053-4628-40.3.211.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/27472568', 'label': 'The Role of Vitamin D Receptor Polymorphisms on Dental Caries.'}]}, 'descriptionModule': {'briefSummary': 'VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults.', 'detailedDescription': 'To date, genes can be grouped into categories based on the factor influencing dental caries. The major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits.\n\nTFIP11 and VDR genes are related to enamel formation genes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult be between 24 and 40 years old\n* subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT\\>13.9\n\nExclusion Criteria:\n\n* systemic or genetic disorders\n* orthodontic appliances\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT04124718', 'briefTitle': 'VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Association Between Enamel Gene Variants and Dental Caries in Adults', 'orgStudyIdInfo': {'id': '2019-204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high caries experience', 'description': '80 adults will be allowed in the high caries experience group according to DMFT index DMFT\\>13.9', 'interventionNames': ['Genetic: high caries experience']}, {'label': 'low caries experience', 'description': '80 adults will be allowed in the high caries experience group according toDMFT index DMFT≤4', 'interventionNames': ['Genetic: high caries experience']}], 'interventions': [{'name': 'high caries experience', 'type': 'GENETIC', 'otherNames': ['DNA isolation, genotyping'], 'description': 'DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit', 'armGroupLabels': ['high caries experience', 'low caries experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53000', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Recep Tayyip Erdogan University Dentistry Faculty', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'overallOfficials': [{'name': 'Gül Yıldız Telatar, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Recep Tayyip Erdogan University Dentistry Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available within 6 months of study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gul Yildiz Telatar', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}