Skip to main content
OpenTrials
Completed

NCT Number: NCT06588049

Nitrate Mouth Rinse and the Oral Microbiome

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dalhousie University

Halifax, Nova Scotia, B3H4R2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beet Root

Dietary Supplement

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

Water

Other

Water used as a mouth rinse

Primary outcomes

  1. 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

  1. Blood Pressure

    Time frame: 2 weeks

    Systolic and diastolic pressures

  2. Nitric Oxide

    Time frame: 2 weeks

    Salivary samples will be obtained to determine Nitric Oxide levels

Sponsors and collaborators

Lead sponsor

Dalhousie University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.