Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Differences of at least 1mm between groups for clinical attachment level changes
研究概览
简要总结
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).
Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.
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)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥14 natural teeth, excluding third molars
- •≥10 posterior teeth
- •≥35 years old
- •≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm
- •Bleeding on probing ≥20% of sites
- •Extensive bone loss determined radiographically
排除标准
- •Periodontal treatment before the time of examination
- •Systemic illness
- •Pregnancy
- •Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
结局指标
主要结局
Differences of at least 1mm between groups for clinical attachment level changes
时间窗: baseline, 3, 6 months
次要结局
- Differences between groups for probing depth changes(baseline, 3, 6 month)
- Differences between groups for bleeding on probing changes(baseline, 3, 6 months)
- Differences between groups for plaque index changes(baseline, 3, 6 months)
- Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid(baseline, 3, 6 months)
- Differences between groups for levels of periodontal pathogens changes(baseline, 3, 6 months)
研究者
Jorge Gamonal
Professor
University of Chile