Nitric OxideNCT06588049
Nitrate Mouth Rinse and the Oral Microbiome
A study testing Beet Root and Water in people with Nitric Oxide and Oral Microbiome, run by Dalhousie University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nitric Oxide, Oral Microbiome
- What is being tested?
- Beet Root and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 14 Aug 2024to 16 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Beet Root, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet RootDietary supplement
Beet Root powder used as a mouth rinse in suspension with water
WaterOther
Water used as a mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
Blood Pressure
Systolic and diastolic pressures
Measured: 2 weeks
Nitric Oxide
Salivary samples will be obtained to determine Nitric Oxide levels
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Aug 2024
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitric OxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leigha Rock, Dalhousie University
- Investigators
- Leigha Rock, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588049
- Sponsor's protocol ID
- 2024-7166
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentifed data and sequencing will be uploaded to a public repository such as the Gene Expression Omnibus.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrate Mouth Rinse and the Oral Microbiome
- ClinicalTrials.gov ID
- NCT06588049
- Acronym / sponsor ID
- 2024-7166
- Conditions
- Nitric Oxide, Oral Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate Mouth Rinse | Experimental | Dietary Supplement: Beet RootNitrate 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 | Placebo comparator | Other: WaterWater mouth rinse swished in mouth for 30 seconds and then expectorated once daily for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- You are between the ages of 18 and 40. Have no uncontrolled systemic diseases.
- Asthma
- Type 1 Diabetes Mellitus
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet RootBeet Root powder used as a mouth rinse in suspension with water | Dietary supplement | Nitrate Mouth Rinse |
| WaterWater used as a mouth rinse | Other | Water Mouth Rinse |
Primary outcome
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.
2 secondary outcomes
Blood Pressure
Time frame: 2 weeks
Nitric Oxide
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. deidentifed data and sequencing will be uploaded to a public repository such as the Gene Expression Omnibus.
Related trials for Nitric Oxide
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingObservational study
Metabolic Changes in Heart Failure Patients Treated With Vericiguat
Heart Failure, Worsening Heart Failure
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
Endothelial Function
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigha Rock, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet Root and Water in people with Nitric Oxide and Oral Microbiome, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial composition (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.