NCT04228861

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 7, 2020

Last Update Submit

January 14, 2020

Conditions

Streptococcus Mutans

Keywords

Familial transmissionCandidaLactobacillusS. mutansnewborn

Outcome Measures

Primary Outcomes (3)

  • Acquisition of the oral streptococcus mutans in infants

    Counts of oral streptococcus mutans

    first 24 hours after birth

  • Acquisition of the oral streptococcus mutans in infants

    Counts of oral streptococcus mutans

    at 1 month old

  • Acquisition of the oral streptococcus mutans in infants

    Counts of oral streptococcus mutans

    4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby

Secondary Outcomes (3)

  • Acquisition of the oral Lactobacillus and candida spp. in infants

    first 24 hours after birth

  • Acquisition of the oral Lactobacillus and candida spp. in infants

    at 1 month old

  • Acquisition of the oral Lactobacillus and candida spp. in infants

    4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby

Eligibility Criteria

Age30 Minutes - 2 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • none of the infants or their families had systemic disease

You may not qualify if:

  • the infants or their families have systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, 44280, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

salivary

MeSH Terms

Conditions

Torulopsis

Study Officials

  • gülsüm duruk

    Inonu University

    STUDY DIRECTOR

  • zehra b erel

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 14, 2020

Study Start

January 1, 2018

Primary Completion

May 20, 2018

Study Completion

January 25, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

TU(1)