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临床试验/NCT04137419
NCT04137419已完成不适用

Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial

University of Ljubljana2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月11日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rok Gašperšič

Assist. Prof.

University of Ljubljana

研究点 (2)

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