Nitrate Mouth Rinse and the Oral Microbiome

NCT06588049 | Completed

• 1 other identifier: 2024-7166
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Nitric Oxide; Oral Microbiome

Outcome Measures

Primary Outcomes (1)

• Microbial composition

  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.

  2 weeks

Secondary Outcomes (2)

• Blood Pressure

  2 weeks

• Nitric Oxide

  2 weeks

Study Arms (2)

Nitrate Mouth Rinse

EXPERIMENTAL

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.

Dietary Supplement: Beet Root

Water Mouth Rinse

PLACEBO COMPARATOR

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

Other: Water

Interventions

Beet Root DIETARY_SUPPLEMENT

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

Nitrate Mouth Rinse

Water OTHER

Water used as a mouth rinse

Water Mouth Rinse

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H4R2, Canada

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Leigha Rock, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - School of Dental Hygiene

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: August 14, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: September 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)