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临床试验/NCT06588049
NCT06588049已完成不适用

Nitrate Mouth Rinse and the Oral Microbiome

Dalhousie University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年8月14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
21
试验地点
2
主要终点
Microbial composition

研究概览

简要总结

The study is aimed to determine if changes to the oral microbiome occur after the use of a nitrate rich mouth rinse. Participants with be asked to use either a controlled (water) mouthrinse once daily for 2 weeks while maintaining normal oral hygiene practices, or use the nitrate rich mouthrinse once daily for 2 weeks.

Primary Outcome measures:

-changes in the composition of the oral microbiome

Secondary Outcome measures

  • Blood Pressure
  • Salivary Nitric Oxide Levels

详细描述

Nitrate is found in high concentrations in beet root, and as such we will use a beet root based product as a daily mouth rinse (Swish and Spit) as a part of the participants daily oral hygiene regimen and collect the participants biofilm before and after 2 weeks of regular use. We will then analyze the data using 16s rRNA sequencing to evaluate the changes in alpha diversity, beta diversity and the absolute and relative differential abundance of nitrate reducing bacteria in the oral microbiome. We will also collect salivary samples to evaluate NO levels, as well as measure blood pressure pre and post treatment.

After this study's completion, we expect to have gained new knowledge on nitrate's influence on the oral microbiome's composition. Gaining this knowledge will allow better public understanding of the effects oral hygiene products have on their oral and systemic health. In addition, the knowledge gained could encourage further investigations into how to better formulate oral hygiene products for improved health and performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • You are between the ages of 18 and
  • Have no uncontrolled systemic diseases.
  • Participants with mild chronic conditions such as:
  • Type 1 Diabetes Mellitus

排除标准

  • You are under the age of
  • You have uncontrolled systemic diseases, or acute infections.
  • You are taking prescription, antibiotics, probiotics, or antimicrobial mouthrinses.
  • You have a documented true allergy (i.e Hives, Swelling of lips/throat) Soy, Nuts, Seeds, Dairy, Egg products, Fish/Shellfish or Wheat.
  • The presence of acute or chronic oral conditions including:
  • Herpes Simplex Virus (recent cold sores)
  • Stomatitis
  • Oral Lichen Planus
  • Angular Cheilitis
  • Candidiasis
  • Necrotizing Gingival Diseases
  • Other inflammatory or infectious pathologies
  • Active dental caries "cavities"
  • Any other periodontal diagnosis other than 'Healthy Periodontium' or localized gingivitis

结局指标

主要结局

Microbial composition

时间窗: 2 weeks

16s rRNA sequencing will be used to explore alpha and beta diversity pre- and post-intervention. Absolute and relative differential abundance will be examined. Functional prediction analysis will be explored.

次要结局

  • Blood Pressure(2 weeks)
  • Nitric Oxide(2 weeks)

研究者

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

Leigha Rock

Director - School of Dental Hygiene

Dalhousie University

研究点 (2)

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