Nitrate Mouth Rinse and the Oral Microbiome

NCT ID: NCT06588049

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2025-05-16

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.

Conditions

Nitric Oxide; Oral Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nitrate Mouth Rinse

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.

Group Type: EXPERIMENTAL

Beet Root

Intervention Type: DIETARY_SUPPLEMENT

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

Water Mouth Rinse

Water mouth rinse swished in mouth for 30 seconds and then expectorated once daily for 14 consecutive days.

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: OTHER

Water used as a mouth rinse

Interventions

Beet Root

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

Intervention Type: DIETARY_SUPPLEMENT

Water

Water used as a mouth rinse

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dalhousie University

OTHER

Sponsor Role: lead

Responsible Party

Leigha Rock

Director - School of Dental Hygiene

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leigha Rock, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

2024-7166

Identifier Type: -

Identifier Source: org_study_id