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临床试验/NCT02809313
NCT02809313Unknown2 期

Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up

Jorge Gamonal1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年3月1日最近更新:
适应症

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 between groups for bleeding on probing 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 sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will be used once per day during 3 months.

详细描述

Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus rhamnosus, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus rhamnosus as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia and A. viscosus) in the experimental group compared with the control. Association between clinical and microbiological parameters.

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
17 Years 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Gingivitis
  • Gingival index > 1.5 (> 10 % of the sites examined)
  • Index increased bleeding on probing 10% of the sites surveyed
  • Probing Depth < 3 mm
  • Systemically healthy (except for the presence of gingivitis)
  • Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study

排除标准

  • Patients who develop systemic disease during the study.
  • Patients who have to ingest antibiotics and / or antiinflammatories during the study.
  • If you are a woman becomes pregnant during the study.

结局指标

主要结局

Differences between groups for bleeding on probing changes

时间窗: baseline, 3 month, 6 month

次要结局

  • Differences between groups for detection of periodontal pathogens(baseline, 3 month, 6 month)
  • Differences between groups for levels of periodontal pathogens changes(baseline, 3 month, 6 month)
  • Differences between groups for gingival index(baseline, 3 month, 6 month)

研究者

发起方
Jorge Gamonal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jorge Gamonal

Professor

University of Chile

研究点 (1)

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