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

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.

Study Overview

• Status: Completed
• Conditions: Streptococcus Mutans

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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44280
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 2 hours (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• none of the infants or their families had systemic disease

Exclusion Criteria:

• the infants or their families have systemic disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of the oral Lactobacillus and candida spp. in infants	Counts of oral Lactobacillus and candida spp	first 24 hours after birth
Acquisition of the oral Lactobacillus and candida spp. in infants	Counts of oral Lactobacillus and candida spp	at 1 month old
Acquisition of the oral Lactobacillus and candida spp. in infants	Counts of oral Lactobacillus and candida spp	4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Director: gülsüm duruk, Inonu University; Principal Investigator: zehra b erel, Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 20, 2018
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: newborn; Candida; Lactobacillus; S. mutans; Familial transmission
• Other Study ID Numbers: 963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I can think of sharing after becoming a publication in a journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No