Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT04228861
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Oral Microflora of Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536972', 'term': 'Torulopsis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'salivary'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acquisition of the oral streptococcus mutans in infants', 'timeFrame': 'first 24 hours after birth', 'description': 'Counts of oral streptococcus mutans'}, {'measure': 'Acquisition of the oral streptococcus mutans in infants', 'timeFrame': 'at 1 month old', 'description': 'Counts of oral streptococcus mutans'}, {'measure': 'Acquisition of the oral streptococcus mutans in infants', 'timeFrame': '4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby', 'description': 'Counts of oral streptococcus mutans'}], 'secondaryOutcomes': [{'measure': 'Acquisition of the oral Lactobacillus and candida spp. in infants', 'timeFrame': 'first 24 hours after birth', 'description': 'Counts of oral Lactobacillus and candida spp'}, {'measure': 'Acquisition of the oral Lactobacillus and candida spp. in infants', 'timeFrame': 'at 1 month old', 'description': 'Counts of oral Lactobacillus and candida spp'}, {'measure': 'Acquisition of the oral Lactobacillus and candida spp. in infants', 'timeFrame': '4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby', 'description': 'Counts of oral Lactobacillus and candida spp'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Familial transmission', 'Candida', 'Lactobacillus', 'S. mutans', 'newborn'], 'conditions': ['Streptococcus Mutans']}, 'descriptionModule': {'briefSummary': 'The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the infant. The investigators investigated of colonization of Streptococcus mutans, Lactobacillus spp., and Candida spp. in oral cavities of infants and their transmission to the infants.', 'detailedDescription': 'Study sample size and design: When α = 0.05, 1-β (power) = 0.80 were taken to determine the sample volume, it was calculated that at least 46 babies should be sampled for 6 months to have an average amount of S. mutans change of 1.87 units. Considering the losses that may occur during the follow-up, the study was started by taking samples from 60 systemically healthy newborns.\n\nThe study commenced with 60 newborns and was completed with 47 infants due to losses during the follow-up. Oral swab samples were taken from 47 healthy infants within the first 24 hours after birth, at 1 month old and during the first tooth eruption. Saliva samples were taken from the mothers of all the infants and from the fathers of 20 of the infants in the last meeting.\n\nLast interview with the parents, their oral examinations were performed, and their findings were processed as decayed (D), filled (F) and missing (M) teeth in accordance with the World Health Organization criteria, with the DMF (decayed, missing and filled) index being calculated. Furthermore, saliva samples were taken from the parents at the last interview. A questionnaire form including the sex of the infant, type of delivery, birth weight, and nutritional habits of the infant during the follow-up was filled in by gaining information from the parents on the first day and during the follow-ups.\n\nSwab samples taken from infants with sterile swabs were transferred to the laboratory by placing sterile saline solution into dispensed 2 ml screw cap tubes. Sterile urine collection containers of 50 ml were used to collect saliva samples from the parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'minimumAge': '30 Minutes', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was conducted in two centers - Turgut Özal Medical Center and Malatya Training and Research Hospital. Between January and May 2018, healthy newborns born in these two hospitals were followed up.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* none of the infants or their families had systemic disease\n\nExclusion Criteria:\n\n* the infants or their families have systemic disease'}, 'identificationModule': {'nctId': 'NCT04228861', 'briefTitle': 'Investigation of Oral Microflora of Infants', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Investigation of Colonization of Streptococcus Mutans, Lactobacillus Spp. and Candida Spp. in Oral Microflora in Infancy and Transmission From the Parent to the Infant', 'orgStudyIdInfo': {'id': '963'}}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu university', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'gülsüm duruk', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inonu University'}, {'name': 'zehra b erel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'I can think of sharing after becoming a publication in a journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'Zehra Beyza Erel', 'investigatorAffiliation': 'Inonu University'}}}}