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Nitrate Mouth Rinse and the Oral Microbiome

Nitrate Mouth Rinse and the Oral Microbiome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06588049
Enrollment
21
Registered
2024-09-19
Start date
2024-08-14
Completion date
2025-05-16
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nitric Oxide, Oral Microbiome

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.

Interventions

DIETARY_SUPPLEMENTBeet Root

Beet Root powder used as a mouth rinse in suspension with water

OTHERWater

Water used as a mouth rinse

Sponsors

Dalhousie University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* You are between the ages of 18 and 40. Have no uncontrolled systemic diseases. Participants with mild chronic conditions such as: * Asthma * Type 1 Diabetes Mellitus

Exclusion criteria

* You are under the age of 18. * 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

Design outcomes

Primary

MeasureTime frameDescription
Microbial composition2 weeks16s 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

MeasureTime frameDescription
Blood Pressure2 weeksSystolic and diastolic pressures
Nitric Oxide2 weeksSalivary samples will be obtained to determine Nitric Oxide levels

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026