Nitrate Mouth Rinse and the Oral Microbiome

Not Applicable

Recruiting

• Conditions: Nitric Oxide; Oral Microbiome
• Interventions: Dietary Supplement: Beet Root; Other: Water

• Registration Number: NCT06588049
• Lead Sponsor: Dalhousie University

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 Timeline

• Study Start: 2024-08-14
• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Primary Completion: 2025-08-14
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrate Mouth Rinse	Beet Root	Nitrate suspension with approximately 50-100mg nitrates formulated with water swished in mouth for 30 seconds and then expectorated once daily for 14 consecutive days.
Water Mouth Rinse	Water	Water mouth rinse swished in mouth for 30 seconds and then expectorated once daily for 14 consecutive days.

Primary Outcome Measures

Name	Time	Method
Microbial composition	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 Outcome Measures

Name	Time	Method
Blood Pressure	2 weeks	Systolic and diastolic pressures
Nitric Oxide	2 weeks	Salivary samples will be obtained to determine Nitric Oxide levels

Trial Locations

Locations (1)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada