Investigation of Oral Microflora of Infants

Streptococcus Mutans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228861
• Other study ID #: 963
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: January 2020
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 25, 2019
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Hours

Eligibility

Inclusion Criteria:

• none of the infants or their families had systemic disease

Exclusion Criteria:

• the infants or their families have systemic disease

Related Conditions & MeSH terms

• Streptococcus Mutans

Locations

Country	Name	City	State
Turkey	Inonu university	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of the oral streptococcus mutans in infants	Counts of oral streptococcus mutans	first 24 hours after birth
Primary	Acquisition of the oral streptococcus mutans in infants	Counts of oral streptococcus mutans	at 1 month old
Primary	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	Acquisition of the oral Lactobacillus and candida spp. in infants	Counts of oral Lactobacillus and candida spp	first 24 hours after birth
Secondary	Acquisition of the oral Lactobacillus and candida spp. in infants	Counts of oral Lactobacillus and candida spp	at 1 month old
Secondary	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