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Investigation of Oral Microflora of Infants

Investigation of Colonization of Streptococcus Mutans, Lactobacillus Spp. and Candida Spp. in Oral Microflora in Infancy and Transmission From the Parent to the Infant

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04228861
Enrollment
47
Registered
2020-01-14
Start date
2018-01-01
Completion date
2019-01-25
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcus Mutans

Keywords

Familial transmission, Candida, Lactobacillus, S. mutans, newborn

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.

Detailed description

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. The 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. Last 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. Swab 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.

Interventions

None listed

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Minutes to 2 Hours
Healthy volunteers
Yes

Inclusion criteria

* none of the infants or their families had systemic disease

Exclusion criteria

* the infants or their families have systemic disease

Design outcomes

Primary

MeasureTime frameDescription
Acquisition of the oral streptococcus mutans in infantsfirst 24 hours after birthCounts of oral streptococcus mutans

Secondary

MeasureTime frameDescription
Acquisition of the oral Lactobacillus and candida spp. in infantsfirst 24 hours after birthCounts of oral Lactobacillus and candida spp

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026