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临床试验/NCT04228861
NCT04228861已完成不适用

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

Inonu University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Acquisition of the oral streptococcus mutans in infants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Minutes 至 2 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • none of the infants or their families had systemic disease

排除标准

  • the infants or their families have systemic disease

结局指标

主要结局

Acquisition of the oral streptococcus mutans in infants

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

Counts of oral streptococcus mutans

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Beyza Erel

research assistant

Inonu University

研究点 (1)

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