Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-28 @ 3:47 AM
Study NCT ID:
NCT04456335
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Supragingival Plaque Microbiome in Early Childhood Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Supragingival plaque sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'V4-16S rRNA and ITS1 rRNA sequencing', 'timeFrame': '6 months', 'description': 'Supragingival plaque samples were collected from the tooth surfaces using a sterile periodontal curette. DNA extraction was performed at Sugenomik Biotechnology Laboratory for library preparation and paired-end Illumina MiSeq PE250 sequencing of the V4 region of bacterial 16S rRNA and fungal ITS1 (internal transcribed spacer 1) rRNA genes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early childhood caries', 'Oral Microbiome', 'Next generation sequencing'], 'conditions': ['Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to characterize the supragingival plaque microbiome in children with early childhood caries and identify potential microorganisms associated with caries.', 'detailedDescription': "Sixty children with and without early childhood caries were recruited from Trakya University Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The International Caries Detection and Assessment System (ICDAS) . Mothers' completed a structured questionnaire on the socio-demographic informations, child's feeding practices and oral hygiene habits. After the oral examination, supragingival plaque samples were collected from the posterior tooth surfaces. Supragingival plaque samples were examined with the Illumina MiSeq new generation sequencing method."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '36 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of sixty children with early childhood caries(n=30) and caries free(n=30)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 36-71 months old children\n* No history of any medical problem\n* No history of antibiotic in the three months prior to sampling\n* Any sign of early childhood caries,\n* Caries free children\n* Mothers accepted to complete a structured questionnaire\n* Children who cooperate for dental examination and sample collection\n\nExclusion Criteria:\n\n* Children older than 71 months\n* Medically compromised\n* Children with antibiotic use history at last three months\n* Children refused dental examination and plaque collection\n* Mothers' refused to complete questionnare"}, 'identificationModule': {'nctId': 'NCT04456335', 'briefTitle': 'Investigation of Supragingival Plaque Microbiome in Early Childhood Caries', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries', 'orgStudyIdInfo': {'id': '2018/269'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caries-free', 'description': 'Caries-free children', 'interventionNames': ['Genetic: Collection of supragingival plaque from caries free children']}, {'label': 'Early childhood caries', 'description': 'Children with early childhood caries', 'interventionNames': ['Genetic: Collection of supragingival plaque from caries free children']}], 'interventions': [{'name': 'Collection of supragingival plaque from caries free children', 'type': 'GENETIC', 'otherNames': ['Collection of supragingival plaque from children with early childhood caries'], 'description': 'Supragingival plaque samples were collected from posterior molar teeth', 'armGroupLabels': ['Caries-free', 'Early childhood caries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Commission of Scientific Research Projects of Trakya University (TÜBAP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'ŞİRİN GÜNER ONUR', 'investigatorAffiliation': 'Trakya University'}}}}