Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in microbial composition in dental
研究概览
简要总结
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
详细描述
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
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)
盲法说明
Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 yrs.
排除标准
- •Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
- •Current smokers
- •Any systemic diseases and current use of any medication with known effect on oral health
- •Use of systemic antibiotics within the latest three months
- •Age < 18 yrs., and age > 30 yrs.
研究组 & 干预措施
Probiotic
In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
干预措施: Oral hygiene discontinuation (Behavioral)
Placebo
In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
干预措施: Oral hygiene discontinuation (Behavioral)
结局指标
主要结局
Changes in microbial composition in dental
时间窗: Baseline vs. Day 14 and Day 28
Changes in alpha and beta diversity of microbial composition
次要结局
- Changes in clinical parameters(Baseline vs. Day 14 and Day 28)
研究者
Daniel Belstrøm, DDS, PhD
DDS, PhD, Dr. odont
University of Copenhagen