Clinical trial NCT06588049: Nitrate Mouth Rinse and the Oral Microbiome
Official title: Nitrate Mouth Rinse and the Oral Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nitric Oxide
Oral Microbiome
Lead sponsor: Dalhousie University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Microbial composition
timeFrame: 2 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 2 weeks
measure: Nitric Oxide
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Leigha Rock, PhD
role: PRINCIPAL_INVESTIGATOR
References: