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HypertensionEarly Phase 1NCT07356271

Effects of Mouthwashes on the Oral Microbiome and Systemic Health

A Early Phase 1 study testing Use of mouthwashes in people with Hypertension, run by University of Plymouth.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Use of mouthwashes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 1 Mar 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All individuals aged 18 years and older will be eligible to take part in this study. Exclusion will apply to individuals who:
  • Are current smokers, due to the well-documented impact of smoking on oral and systemic health.
  • Have a known diagnosis of hypertension, diabetes, or cancer, as these systemic conditions may influence oral microbiome and inflammatory responses.
  • Have taken a course of antibiotics within the last three months, since antibiotics are known to disrupt microbial balance and may confound the interpretation of oral microbiome data.
  • Report allergies to essential oils or to milk proteins, as these ingredients may be present in the study mouthwash and could trigger adverse reactions.
  • In addition, participants who have never previously used a mouthwash will be excluded. This is a precautionary measure designed to avoid even the minimal possibility of adverse responses.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

OVERVIEW

While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis).

Read more

Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment . A recent study completed in 2025 has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice.

This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. . All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

Read the detailed description

PROJECT AIMS

The aim of this project is to determine the role of different mouthwashes on the oral microbiome and its relationship with cardiovascular health. We will achieve this by conducting a double-blinded randomised clinical trial (pilot study) in a primary care dental setting, to investigate (i) the composition of the oral microbiome in different oral niches in periodontal health and disease, and (ii) determine how the oral microbiome is altered by the use of different mouthwashes during oral health and disease, with either , essential oil (EOs), CPCs, hydrogen peroxide (H2O2); all versus placebo (water or saline).

OVERVIEW

While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies suggest that, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis).

Conditions
Hypertension
Being tested
Use of mouthwashes
Keywords
Oral microbiome dysbiosis
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of mouthwashesDrug

    Population

    This study aims to recruit up to 200 participants over a period of 3 years on a part-time basis. Recruitment will be carried out through three sites: (i) the University of Plymouth campus population (as successfully used in earlier studies such as Bescos et al., 2020), (ii) the Peninsula Dental School / Peninsula Dental Social Enterprise (PDSE) triage patient clinics (non-NHS clinics), and (iii) the Southside Dental Practice, a private primary care practice located in Southsea, Portsmouth.

    Sample size was calculated using G*Power software, which showed that usually 20-30 participants per group are enough, depending on whether the focus is clinical outcomes, blood markers, or microbiome changes.

    For this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores.

    The PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In compariso

Study groups in NCT07356271
Study groupRoleWhat they receive
mouthwashesExperimentalPopulation This study aims to recruit up to 200 participants over a period of thr years on a part-time basis. Recruitment will be carried out through three sites: (i) the University of Plymouth campus population (as successfully used in earlier studies such as Bescos et al., 2020), (ii) the Peninsula Dental School / Peninsula Dental Social Enterprise (PDSE) triage patient clinics (non-NHS clinics), and (iii) the Southside Dental Practice, a private primary care practice located in Southsea, Portsmouth. Sample size was calculated using G*Power software, which showed that usually 20-30 participants per group are enough, depending on whether the focus is clinical outcomes, blood markers, or microbiome changes. For this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores. The PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In comparis
Receives: Drug: Use of mouthwashes
placeboExperimentalPopulation This study aims to recruit up to 200 participants over a period of 3 years on a part-time basis. Recruitment will be carried out through three sites: (i) the University of Plymouth campus population (as successfully used in earlier studies such as Bescos et al., 2020), (ii) the Peninsula Dental School / Peninsula Dental Social Enterprise (PDSE) triage patient clinics (non-NHS clinics), and (iii) the Southside Dental Practice, a private primary care practice located in Southsea, Portsmouth. Sample size was calculated using G*Power software, which showed that usually 20-30 participants per group are enough, depending on whether the focus is clinical outcomes, blood markers, or microbiome changes. For this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores. The PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In comparis
Receives: Drug: Use of mouthwashes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effect of mouthwashes on oral microbiome

    EXPECTED OUTCOMES / DELIVERABLES

    One of the main expected outcomes of this study is to provide clear evidence on the clinical effectiveness of commonly used mouthwashes and their effect on oral microbiome and cardiovascular health. It is anticipated that some mouthwashes will significantly reduce dental plaque and bleeding on probing when compared with placebo. Demonstrating these effects will help confirm which products can genuinely support daily oral hygiene and clinical treatment of gum conditions, alongside either beneficial or no effects on the oral microbiome, such that their beneficial effects do not outweigh the risks.

    In participants with good oral health, we thus expect that effective mouthwashes will not only reduce plaque but also maintain a balanced oral microbiome. This means that mouthwashes should support microbiome health, without causing dysbiosis or loss of diversity.

    In participants with gingivitis or periodontal disease, the expectation is that mouthwash

    Measured: three years

Secondary outcomes (1)
  1. effect of mouthwashes on cardiovascular health

    EXPECTED OUTCOMES / DELIVERABLES

    One of the main expected outcomes of this study is to provide clear evidence on the clinical effectiveness of commonly used mouthwashes and their effect on oral microbiome and cardiovascular health. It is anticipated that some mouthwashes will significantly reduce dental plaque and bleeding on probing when compared with placebo. Demonstrating these effects will help confirm which products can genuinely support daily oral hygiene and clinical treatment of gum conditions, alongside either beneficial or no effects on the oral microbiome, such that their beneficial effects do not outweigh the risks.

    In participants with good oral health, we thus expect that effective mouthwashes will not only reduce plaque but also maintain a balanced oral microbiome. This means that mouthwashes should support microbiome health, without causing dysbiosis or loss of diversity.

    In participants with gingivitis or periodontal disease, the expectation is that mouthwash

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study Design and Appointment Structure (workflow) Each participant is required to attend two research appointments : first research appointment - baseline and second research appointment - follow-up (7 days after using the mouthwash). At both visits, health screening, oral checks, and sample collection are repeated. Each appointment is expected to take around one hour, based on timings from our pilot work. These visits are designed to collect baseline information, deliver the intervention (mouthwash or placebo), and then assess short-term changes in oral and biochemical markers following use of the mouthwash.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356271
Sponsor's protocol ID
University of Plymouth
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • References Al-Maweri, S. A., et al. (2025). "The association between the oral microbiome and hypertension: a systematic review." Journal of oral microbiology 17(1): 2459919. Alrashdan, M. S., et al. (2023). "The Effects of Antimicrobial Mouthwashes on Systemic Disease: What Is the Evidence?" International dental journal 73: S82-S88 Aravinth, V., et al. "Comparative evaluation of saltwater rinse with chlorhexidine against oral microbes: a school-based randomized controlled trial " Indian Soc Pedod Prev Dent, 35 (4) (2017), pp. 319-326 Bescos, R., et al. "The comparative effect of propolis and chlorhexidine mouthwash on oral nitrite-producing bacteria and blood pressure regulation." Bescos, R., et al. (2020). "Effects of Chlorhexidine mouthwash on the oral microbiome." Sci Rep 10(1): 5254-5254. Bondonno, C. P., et al. (2015). "Antibacterial Mouthwash Blunts Oral Nitrate Reduction and Increases Blood Pressure in Treated Hypertensive Men and Women." Am J Hypertens 28(5): 572-575. Brookes, Z., et al. (2023). "Antimicrobial Mouthwashes: An Overview of Mechanisms-What Do We Still Need to Know?" International dental journal. Brookes, Z., et al. (2023). "Mouthwash Effects on the Oral Microbiome: Are They Good, Bad, or Balanced?" International dental journal. Burcham, Z. M., et al. (2020). "Patterns of Oral Microbiota Diversity in Adults and Children: A Crowdsourced Population Study." Scientific reports 10(1): 2133. Burton, J. P., et al. (2006). "preliminary study of the effect of probiotic Streptococcus salivarius K12 on oral malodour parameters." Journal of Applied Microbiology 100(4): 754-764. Casarin, M., et al. (2023). "Effect of mouthwashes on gingival healing after surgical procedures: A systematic review." European Journal of Oral Sciences 131(3): e12931-n/a. Caselli, E., et al. (2020). "Defining the oral microbiome by whole-genome sequencing and resistome analysis: the complexity of the healthy picture." BMC Microbiol 20(1): 120-120

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Use of mouthwashes in people with Hypertension, run by University of Plymouth.

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 6 inclusion and 0 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact mimoza cana-bishop, MSc (+447903995399, mimoza.cana-bishop@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect of mouthwashes on oral microbiome (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07356271, which also lists 1 linked publication.

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 17 Feb 2026.

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