Efficacy of Oral Probiotic and Antibiotic 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
- 54
- 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 and azithromycin tablets as an adjunct to scaling and root planning (SRP).
Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.
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
研究组 & 干预措施
Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
干预措施: Talc powder (Other)
Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
干预措施: Periodontal treatment Scaling and root planning (Procedure)
Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
干预措施: Lactobacillus rhamnosus SP1 (Dietary Supplement)
Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
干预措施: Periodontal treatment Scaling and root planning (Procedure)
Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
干预措施: Azithromycin (Drug)
Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
干预措施: Periodontal treatment Scaling and root planning (Procedure)
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, 9 and 12 month
次要结局
- Differences between groups for probing depth changes(baseline, 3, 6, 9 and 12 month)
- Differences between groups for bleeding on probing changes(baseline, 3, 6, 9 and 12 month)
- Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid(baseline, 3, 6, 9 and 12 month)
- Differences between groups for levels of periodontal pathogens changes(baseline, 3, 6, 9 and 12 month)
- Differences between groups for plaque index changes(baseline, 3, 6, 9 and 12 month)
研究者
Jorge Gamonal
Prof
University of Chile