NCT06141083已完成不适用
Effect of TCI188 Probiotic on Oral Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The change of clinical oral measurements- Bleeding on probing (BOP)
研究概览
简要总结
To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over 18 years old
- •Participants suffer from severe periodontal disease throughout the mouth with symptoms at third and fourth stages, do not have immediate indications for the extraction of multiple teeth or complex denture stimulation, and have not undergone periodontal planing within one year.
排除标准
- •Participants have had periodontal or antimicrobial treatment within the past 6 months
- •Participants are smokers, pregnant or with systemic diseases
- •Participants had probiotic supplements or with history of adverse reactions to lactose or fermented dairy products
研究组 & 干预措施
Placebo chewable tablets
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
TCI188 Probiotic chewable tablets
Experimental
干预措施: TCI188 Probiotic (Dietary Supplement)
结局指标
主要结局
The change of clinical oral measurements- Bleeding on probing (BOP)
时间窗: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The values of Bleeding on probing (BOP) was utilized to evaluate oral status.
The change of clinical oral measurements- Probing pocket depth (PPD)
时间窗: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The values of Probing pocket depth (PPD) was utilized to evaluate oral status.
次要结局
- The change of inflammatory markers (IL-10, IL-1beta) of saliva(before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of clinical oral measurements- Plaque index (PI)(before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of clinical oral measurements- Gingival index (GI)(before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of Bad breath(before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of clinical oral measurements- Clinical attachment level (CAL)(before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of oral microflora(before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of liver function biomarkers (AST, ALT) of blood(before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of renal function biomarkers (BUN, CRE) of blood(before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
- The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood(before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks)
研究者
研究点 (1)
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