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临床试验/NCT05859646
NCT05859646已完成不适用

Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora

Didem Sakaryali Uyar2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Lactobacillus spp count

研究概览

简要总结

To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.

详细描述

Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessment was performed by a different researcher who was unaware of the group distributions in which patients were included.

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Every included child had at least 8 tooth with caries.

排除标准

  • Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.

结局指标

主要结局

Lactobacillus spp count

时间窗: 6 month

CFU

S mutans count

时间窗: 6 month

CFU

次要结局

未报告次要终点

研究者

发起方
Didem Sakaryali Uyar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Didem Sakaryali Uyar

Asst. Prof. Dr.

Baskent University

研究点 (2)

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