A Randomized Single-blind, Parallel-arm Multi-center Clinical Trial to Evaluate the Effectiveness and Safety of Lactobacillus Reuteri for Treatment of Periodontitis in a Chinese Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pocket Probing Depth(PPD)
研究概览
简要总结
The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients.
详细描述
Periodontitis is a chronic inflammatory disease with a prevalence of 80% in Chinese adults, which is the main cause of tooth loss in adults. Periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. In the last decade, probiotics therapy using Lactobacillus Reuteri has been applied for periodontitis patients in European countries. But no evidence has been provided for its effectiveness in a Chinese population. The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. The influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Patients diagnosed with periodontitis clinically evident according to International Classification of Periodontal Diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length
- •Natural teeth remaining in the mouth≥ 14
排除标准
- •Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension.
- •Patients with aggressive periodontitis.
- •Patients who received any periodontal treatment in the past 6 months
- •Pregnant or lactating women
- •Patients who smoke
- •Patients in the acute phase of an infectious disease
- •Patients taking bisphosphonate mediation
- •Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months
- •Patients allergic to lactate products
- •Patients who are deemed uncooperative
结局指标
主要结局
Change From Baseline in Pocket Probing Depth(PPD)
时间窗: at 3 months
Distance from the base of the periodontal pocket to the gingival margin(mm)
次要结局
- Number of microorganisms in periodontal pockets(at baseline, 1, 3 and 6 months)
- Change from baseline in Clinical Attachment Level(at baseline, 1, 3 , 6 months)
- Change from baseline in Rate of Bleeding on Probing(at baseline, 1, 3 , 6 months)
- Change from baseline in Pocket Probing Depth(at baseline, 1, 6 months)
- Contents of inflammatory cytokines in periodontal pockets and blood(at baseline, 1, 3 and 6 months)