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临床试验/NCT01738958
NCT01738958已完成不适用

Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Change in enamel porosity

研究概览

简要总结

Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities.

It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software.

The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •two sites with white spot lesions in anterior teeth

排除标准

  • •antibiotic treatment within 2 months

研究组 & 干预措施

Probiotic lactobacilli

Active Comparator

L. reuteri, two times a day for 6 weeks

干预措施: L. retueri (Biological)

Placebo

Placebo Comparator

Placebo tablets, two times a day for 6 weeks

干预措施: Placebo (Biological)

结局指标

主要结局

Change in enamel porosity

时间窗: Baseine and 12 weeks

Change in enamel porosity assed by QLF

次要结局

未报告次要终点

研究者

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

Mette Kirstine Keller

Assistant Professor

University of Copenhagen

研究点 (1)

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