An observational study in Streptococcus Mutans, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 30 Minutes to 2 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Inonu University · Observational
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 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.
Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Time frame: first 24 hours after birth
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Time frame: at 1 month old
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Time frame: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Time frame: first 24 hours after birth
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Time frame: at 1 month old
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Time frame: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Inonu University