ProBiora3 Oral Care Probiotics Usage
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
研究概览
简要总结
The purpose of this study is to determine if an oral probiotic tablet taken once a day for twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and gum disease in a dentally healthy, young adult population.
详细描述
There are over 500 types of bacteria in the mouth. Most of these bacteria do not cause disease. However, some mouth bacteria can cause tooth decay and gum disease. The purpose of a probiotic tablet for the mouth is to put known healthy bacteria in the mouth. This study will compare the effect of the probiotic tablet on the levels of harmful or disease causing bacteria in the mouth to a placebo tablet that does not contain any probiotic bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •minimum of 20 teeth, with only a few fillings
- •good general health
- •willing to use an appropriate method of birth control during the study
- •measurable levels of Streptococcus mutans and one or more of the selected periodontal pathogens
排除标准
- •chronic or acute illness such as heart disease, diabetes, cancer, hepatitis (liver disease) or HIV positive
- •radiation therapy or systemic cancer treatment (chemotherapy)
- •require antibiotics for dental treatment
- •pregnant or planning to become pregnant during the study period
结局指标
主要结局
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
时间窗: 12 weeks
Quantitative RT-PCR analyses for S. mutans in saliva, and A. actinomycetemcomitans, P. intermedia, T. forsythia, F. nucleatum, C. rectus, and E. corrodens in subgingival dental plaque.
次要结局
- Breath odor(12 weeks)
- Teeth whiteness(12 weeks)