[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620334":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":24,"responsibleParty":39,"collaborators":24,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":24,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":24,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":24,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":24},{"fullName":5,"class":6},"University of Plymouth","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mouthwashes","EXPERIMENTAL","Population\n\nThis 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 \u002F 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.\n\nSample 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.\n\nFor this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores.\n\nThe PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In comparis",[13],"Drug: Use of mouthwashes",{"label":15,"type":10,"description":16,"interventionNames":17},"placebo","Population\n\nThis 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 \u002F 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.\n\nSample 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.\n\nFor this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores.\n\nThe PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In comparis",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Use of mouthwashes","Population\n\nThis 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 \u002F 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.\n\nSample 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.\n\nFor this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores.\n\nThe PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In compariso",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"zoe Brookes, PhD","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"mimoza cana-bishop, MSc","CONTACT","+447903995399","mimoza.cana-bishop@plymouth.ac.uk",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Zoe Brookes, PhD","441752586828","zoe.brookes@plymouth.ac.uk",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mimoza Cana-Bishop","Mrs","100620334","early-phase-1-effects-of-mouthwashes-on-the-oral-microbiome-and-systemic-health-100620334",false,"NCT07356271","Effects of Mouthwashes on the Oral Microbiome and Systemic Health","* Inclusion \\& Exclusion\n\nAll individuals aged 18 years and older will be eligible to take part in this study. Exclusion will apply to individuals who:\n\nAre current smokers, due to the well-documented impact of smoking on oral and systemic health.\n\nHave a known diagnosis of hypertension, diabetes, or cancer, as these systemic conditions may influence oral microbiome and inflammatory responses.\n\nHave 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.\n\nReport allergies to essential oils or to milk proteins, as these ingredients may be present in the study mouthwash and could trigger adverse reactions.\n\nIn 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.",true,"ALL","18 Years",{"count":53,"type":54},200,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","OVERVIEW\n\nWhile 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).\n\nMost 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.\n\nThis 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.",[60],"Hypertension",[62],"Oral microbiome dysbiosis","NOT_YET_RECRUITING","2026-02-11",{"date":66,"type":67},"2026-02-17","ACTUAL",{"date":69,"type":54},"2026-02-01",{"date":71,"type":54},"2029-03-01",{"name":5,"class":6}]