Effects of Mouthwashes on the Oral Microbiome and Systemic Health
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- effect of mouthwashes on oral microbiome
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
mouthwashes
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
干预措施: Use of mouthwashes (Drug)
placebo
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
干预措施: Use of mouthwashes (Drug)
结局指标
主要结局
effect of mouthwashes on oral microbiome
时间窗: three years
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
次要结局
- effect of mouthwashes on cardiovascular health(three years)
研究者
Mimoza Cana-Bishop
Mrs
University of Plymouth