Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT06343766
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.
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': 'D005838', 'term': 'Genotype'}, {'id': 'D003945', 'term': 'Diagnosis, Oral'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "DNA was collected from all participants using buccal swabs provided in the Sigma® Cheek Cell Collection Kit in this study. These swabs were gently rubbed on both sides of the buccal mucosa ten times. After removing the plastic sticks from the swabs, the collected swabs were placed in 1.5-ml Eppendorf tubes. These tubes were then stored at +4 °C until genomic DNA extraction. Following a brief centrifugation, DNA purification was performed following the manufacturer's instructions. The purified DNA samples were subsequently stored at -21 °C for future analysis."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility.', 'timeFrame': 'Done immediately following completion of assessment for eligibility of enrolment in the present study', 'description': 'Potential role of alleles or genotypes of enamel encoding genes such as ENAM, AMBN, TUFT1 and KLK4 in the caries-susceptible group and in the caries-resistant group using PCR and sequencing for various SNPs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enamelin (ENAM)', 'Ameloblastin (AMBN)', 'Tuftelin 1 (TUFT1)', 'Kallikrein-related peptidase-4 (KLK4)', 'Dental caries', 'Polymorphisms'], 'conditions': ['Dental Caries Secondary to Polymorphisms', 'Polymorphisms in Enamel Encoding Genes']}, 'descriptionModule': {'briefSummary': 'A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries.', 'detailedDescription': 'The research investigates the distributional discrepancies of specific polymorphic loci ENAM rs3796703, AMBN rs4694075, TUFT1 rs13236243, and KLK4 rs2242670-within the Egyptian population as correlatives and causatives of dental caries susceptibility through the genotyping of enamelin (ENAM rs3796703), ameloblastin (AMBN rs4694075), tuftelin 1 (TUFT1 rs78802584), and kallikrein 4 (KLK4 rs2242670) in 132 adults (males = 74, females = 58) and 72 controls (males = 40, females = 32) referred from various Egyptian hospitals. For each participant, the number of decayed, missing, and filled teeth was charted, and the presence of biofilm/gingivitis/fluorosis was assessed. Bitewing radiographs were taken to detect interproximal caries. In addition, statistical analysis was conducted using Chi-square test, odds ratios, and corresponding P-values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presented to Operative Dentistry Department, Faculty of Dentistry and Outpatient Clinics of University Hospital of October 6 University and referred from various Egyptian hospitals in Greater Cairo, Egypt', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of dental caries or decay in form of discoloration, cavities, or visible enamel softening suggestive of potential caries (Caries-susceptible group)\n* Caries-free patients as control group (Caries-resistant group)\n\nExclusion Criteria:\n\n* The presence of white spots or fluorosis, indicating enamel defects or demineralization, required exclusion from the study.'}, 'identificationModule': {'nctId': 'NCT06343766', 'briefTitle': 'Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Polymorphisms in ENAM, AMBN, and KLK4 Predispose Egyptian Adults to Dental Caries: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'RECO6U/24-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Caries-susceptible group', 'interventionNames': ['Genetic: DNA collation and genotyping']}, {'label': 'Control group', 'description': 'Caries-resistant group', 'interventionNames': ['Genetic: DNA collation and genotyping']}], 'interventions': [{'name': 'DNA collation and genotyping', 'type': 'GENETIC', 'otherNames': ['Dental examinations'], 'description': 'DNA collation and genotyping of specific genes ENAM rs3796703, AMBN rs4694075), TUFT1 rs78802584 and KLK4 rs2242670 through PCR and sequencing for various SNPs\n\nDental examinations by comparing dental covariates such as the number of DMF-T index, presence of biofilm, gingivitis, fluorosis, and detection of interproximal caries with caries progression.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, October 6 University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Hassan M. Negm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, October 6 University, Giza, Egypt; +201222323200; Hassannegm.dent@o6u.edu.eg'}, {'name': 'Rania R. Omar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, October 6 University, Giza, Egypt; rania.rashad@dentistry.cu.edu.eg'}, {'name': 'Amina F. Farag, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, October 6 University, Giza, Egypt; AminaFouadFarag.dent@o6u.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amina Fouad Farag', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Oral and Maxillofacial Pathology, Oral Pathology Department, Faculty of Dentistry', 'investigatorFullName': 'Amina Fouad Farag', 'investigatorAffiliation': 'October 6 University'}}}}