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临床试验/NCT02801773
NCT02801773Unknown2 期

Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis. Randomized Clinical Trials

University of Chile1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6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
20
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 trials is to evaluate the effects of Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically at baseline, 3 and 6 month 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 lozenges will be used once per day during 3 month.

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 reuteri, 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 reuteri 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 probiotic lozenges Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in bleeding and gingival index in the experimental group compared with the control.

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 sites examined)
  • Bleeding index > 10 % sites surveyed
  • Probing Depth < 4 mm
  • Systemically healthy (except for the presence of gingivitis)
  • Patients who have not received periodontal treatment before the test and no intake of medicines such antibiotic and/ or anti-inflammatory in the last 3 months prior to the start of the study

排除标准

  • Patient who develop systemic disease during the study
  • Patient who have to ingest antibiotic/ or anti-inflammatories 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, 1, 3 month

次要结局

  • Differences between groups for gingival index(baseline, 1, 3 month)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Gamonal

Proffesor

University of Chile

研究点 (1)

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