Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in microbial composition in dental plaque
研究概览
简要总结
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
详细描述
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks
. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.
Clinical measurements and sampling will be performed at baseline, week 6 and week 12.
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
- Treatment
- 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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis stage 2-3, Grade B-C, generalized
排除标准
- •• Use of systemic antibiotics within the latest three months.
研究组 & 干预措施
Placebo
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
干预措施: Placebo (Dietary Supplement)
Probiotic
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in microbial composition in dental plaque
时间窗: Baseline vs. week 6 and week 12
Changes in alpha and beta diversity of microbial composition
次要结局
- Changes in dental plaque(Baseline vs. week 6 and week 12)
- Changes in bleeding on probing(Baseline vs. week 6 and week 12)
- Changes in probing pocket depth(Baseline vs. week 6 and week 12)
- Changes in clinical attachment level(Baseline vs. week 6 and week 12)
- Changes in salivary levels of inflammatory cytokines(Baseline vs. week 6 and week 12)
研究者
Daniel Belstrøm, DDS, PhD
Associate professor, dr. odont., PhD, DDS
University of Copenhagen