Effects of Mouthwashes on the Oral Microbiome and Systemic Health

NCT07356271 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: University of Plymouth
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 protective role of the oral microbiome (dysbiosis). 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.

Conditions

Hypertension

Keywords

Oral microbiome dysbiosis

Outcome Measures

Primary Outcomes (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

  three years

Secondary Outcomes (1)

• effect of mouthwashes on cardiovascular health

  three years

Study Arms (2)

mouthwashes

EXPERIMENTAL

Population 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

Drug: Use of mouthwashes

placebo

EXPERIMENTAL

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 comparis

Drug: Use of mouthwashes

Interventions

Use of mouthwashes DRUG

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

mouthwashes; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* Inclusion \& Exclusion 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Plymouth: lead

Related Publications (1)

• 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

  BACKGROUND

Related Links

• Library of Plymouth university that covers the main databases

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• zoe Brookes, PhD

  University of Plymouth

  STUDY DIRECTOR

Central Study Contacts

mimoza cana-bishop, MSc

CONTACT

+447903995399; mimoza.cana-bishop@plymouth.ac.uk

Zoe Brookes, PhD

CONTACT

441752586828; zoe.brookes@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share