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临床试验/NCT02597192
NCT02597192已完成不适用

Professor Doctor, Cukurova University Faculty of Dentistry

Cukurova University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
gingival index scores

研究概览

简要总结

Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis.

Materials and methods: In this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8 weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.

详细描述

The administration of micro-organisms to improve the human health was already promoted by the Nobel prizewinning scientist Eli Metchnikoff in the beginning of the 20th century. However, it took several decades for this subject to become a topic of interest in medicine. At this moment these micro-organisms are called "probiotics" and defined as "living microorganisms which, when administered in adequate amounts, confer a health benefit for the host" (http://www.who.int/foodsafety/publications/fs_management/en/probiotics.pdf). Over the past decade probiotics have been extensively investigated from the perspective of oral health. It was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva and/or plaque during their usage, that they have a positive influence on bad breath and that they can improve the results of scaling and root planing in periodontitis patients. A positive effect of probiotic usage on plaque accumulation and gingivitis measurements in gingivitis patients was also shown.To the investigators knowledge, at this moment no trials are available describing the effect of other probiotic genera on gingivitis. Since it is clear that probiotic effects are strain, dosage and mode of application dependent, the aim of this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush cleaner with Bacillus subtilis, Bacillus megaterium, and Bacillus pumulus versus a placebo in patients with generalized gingivitis.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •diagnosed with plaque-induced gingivitis
  • •a pocket probing depth not more than 5 mm
  • •at least 20 natural teeth
  • •no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months

排除标准

  • •patients with hematologic disorders, or other systemic illness
  • •pregnant and lactating females
  • •patients undergoing orthodontic treatment
  • •those with smoking habits were excluded.

研究组 & 干预措施

Active test group

Active Comparator

probiotic oral hygiene products with Bacillus (PIP, Chrisal)

干预措施: probiotic oral hygiene products with Bacillus (PIP, Chrisal) (Other)

Placebo group

Placebo Comparator

oral hygiene products without Bacillus

干预措施: oral hygiene products without Bacillus (Other)

结局指标

主要结局

gingival index scores

时间窗: 8weeks

次要结局

  • plaque index scores(8weeks)

研究者

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

Onur Ozcelik

Professor

Cukurova University

研究点 (1)

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