Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Residual diseased site number
研究概览
简要总结
ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth > 4 mm and bleeding on probing.
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
Placebo, masked evaluator
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •periodontitis stage III or IV
- •at least 20 teeth for evaluation
- •besides solitary crowns, no other prosthodontic tooth replacements
- •good systemic health
- •smoking less than 10 cig/day
排除标准
- •periodontal treatment lass than 1 year before inclusion
- •antibiotic therapy in the last 6 months
- •chronic systemic diseases with the impact on periodontium or healing process
- •medication with the impact on periodontium or healing process
结局指标
主要结局
Residual diseased site number
时间窗: 3 months
No of sites with probing pocket depth (PPD) \> 4 mm and bleeding on probing after treatment
Gingival bleeding index
时间窗: 3 months
Percentage od bleeding sites after gentle probing of gingival sulcus
次要结局
- Recession(3 months)
- Bleeding on probing(3 months)
- Probing pocket depth reduction(3 months)
研究者
Rok Gašperšič
Assist. Prof.
University of Ljubljana
