Nitrate Mouth Rinse and the Oral Microbiome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dalhousie University
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Microbial composition
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •You are between the ages of 18 and
- •Have no uncontrolled systemic diseases.
- •Participants with mild chronic conditions such as:
- •Type 1 Diabetes Mellitus
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Microbial composition
Time Frame: 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.
Secondary Outcomes
- Blood Pressure(2 weeks)
- Nitric Oxide(2 weeks)
Investigators
Leigha Rock
Director - School of Dental Hygiene
Dalhousie University