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临床试验/NCT01657539
NCT01657539已完成2 期

Effects of Yogurt Containing Bifidobacterium Animalis Ssp. Lactis dn- 1173010 Probiotics in the Composition of Biofilms and Saliva of Orthodontic Patients: a Crossover, Double-blind, Randomized and Placebo Controlled Clinical Trial.

Federal University of Pelotas2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Cariogenic bacteria reduction

研究概览

简要总结

Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. Experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values before and after the treatment will be compared with Wilcoxon's test (p<0.05).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • excellent oral health
  • patients under bimaxillary orthodontic treatment

排除标准

  • any chronic disease
  • antibiotics and/or antimicrobial use in the previous 3 weeks
  • topic fluoride or chlorhexidine use in the previous 3 weeks
  • presence of cavitated or active carious lesions
  • patients with intolerance to lactose.

结局指标

主要结局

Cariogenic bacteria reduction

时间窗: 14 days

The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient

次要结局

  • Patient discomfort with the treatment(14 days after intervention)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximiliano Sergio Cenci

Coordinator of Clinical Trial, Graduate of Program of Dentistry

Federal University of Pelotas

研究点 (2)

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