[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659118":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":56,"studyPopulation":57,"armGroups":58,"interventions":74,"overallOfficials":54,"centralContacts":79,"locations":88,"responsibleParty":111,"collaborators":115,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":54,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":54,"enrollmentInfo":129,"targetDuration":54,"studyType":132,"phases":54,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":143,"whyStopped":54,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"University of Plymouth","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":47,"otherOutcomes":54},[9,13,17,20,23,26,29,32,35,38,41,44],{"measure":10,"description":11,"timeFrame":12},"Blood oestrogen","Blood oestrogen from blood drawn from finger prick, at baseline screening appointment.","Observational, 1 timepoint assessment. From October 2026 to July 2027.",{"measure":14,"description":15,"timeFrame":16},"Blood pressure","Blood pressure measured in triplicate on left arm after a 10 minute rest period, at baseline screening appointment. Intervention at day 1 and 7 days post intervention.","Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.",{"measure":18,"description":19,"timeFrame":16},"Oral bleeding","Oral bleeding via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":21,"description":22,"timeFrame":16},"Volatile breath compounds","The patient will also be asked to blow into a tube for approximately 10-seconds to collect and immediately analyse volatile sulphur compounds associated with bacteria.",{"measure":24,"description":25,"timeFrame":16},"Perception of oral soft tissue 'comfort'","Dry mouth scoring system to be asked of the participants.",{"measure":27,"description":28,"timeFrame":16},"Oral plaque","Oral plaque via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":30,"description":31,"timeFrame":16},"Probing pocket depth","Probing pocket depth via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":33,"description":34,"timeFrame":16},"BPE","Oral BPE via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":36,"description":37,"timeFrame":16},"Height","Height at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":39,"description":40,"timeFrame":16},"Weight","Weight at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":42,"description":43,"timeFrame":16},"Blood cholesterol","Blood cholesterol at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":45,"description":46,"timeFrame":16},"Blood glucose","Blood glucose at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",[48,51],{"measure":49,"description":50,"timeFrame":16},"Saliva including ammonia, ph, buffering capcity, lactate, glucose, interleukins, nitrate, nitrite, and oral nitrate reducing capacity.","Biochemical markers from saliva including ammonia, ph, buffering capcity, lactate, glucose, interleukins, nitrate, nitrite, and oral nitrate reducing capacity at baseline screening appointment. Intervention at day 1 and 7 days post intervention.",{"measure":52,"description":53,"timeFrame":16},"Oral bacteria abundance","Oral microbiome analysis via either 16s or WGS techniques.",null,{"allocation":54,"interventionModel":54,"interventionModelDescription":54,"primaryPurpose":54,"observationalModel":6,"timePerspective":6,"maskingInfo":54},"During the menopause women are more likely to get dry mouth, burning mouth, gum disease and\u002For dental decay as they get older. Women are also more likely to get dry and burning mouth compared to men. We still don't know why this happens, but it might be related to declines in female hormones as they get older. This study will identify oral health changes related to changes in female hormonal status. during ageing.\n\nOral diseases are mainly cause by bacteria, and modern techniques (metagenomics) allow us to study millions of bacteria at the same time (oral microbiome), to identify which ones are associated with healthy mouths and which are associated with disease. We want to observe whether menopausal women, especially those with lower oestogen, have more unhealthy oral bacteria, compared to women of a younger age.\n\nWe also know that poor oral health is associated with systemic disease, for example diabetes and cardiovascular disease, so the study will assess overall health at the same time as your oral health. This approach called 'putting the mouth back in the body', as there is evidence that improving your oral health can improve general health too.\n\nFinally, we also want to produce data to make sure women receive the appropriate dental care they need at a time of increased risk. Knowing this we will eventually be able to provide dental diagnoses and treatments with equal effectiveness in both men and women. The second part of this study will therefore investigate the oral health effects of over the counter mouthwash (non-medicinal; essential oils) in menopausal women.\n\nIn summary, we are interested in whether changes in hormone levels during different stages of menopause are linked to changes in oral health, saliva composition, and the bacteria in the mouth. We are also looking at whether hormonal changes are associated with symptoms such as dry mouth, as well as broader health measures including blood pressure and metabolic health.","The study will be conducted at the Peninsula Dental School (PDS; University of Plymouth, UK) Dental Clinical Education Facilities, Derriford Research Facility and Link Laboratories.\n\nFemale participants, aged 18+ will be recruited from the dental school site if they consent to being contacted about research (PDSE consent to research policy). Participants who agree to participate will be sent a text confirming their appointment, and a subsequent reminder text within 4 days of their appointment. Participants who agree to participate will be forwarded via email or letter, the study information sheet. Participants will be free to withdraw from the study at any point.\n\nAll patients who partake in this trial have a dentist\u002Fdental care provided via PDSE and will be referred should any dental issues arise, no clinical treatment occurs as part of this research. Patients therefore continue clinical treatment and emergency appointments with students or staff clinics unaffected by this re",[59,62,65,70],{"label":60,"type":54,"description":61,"interventionNames":54},"18-32 years","females aged 18-32 years (n=30)",{"label":63,"type":54,"description":64,"interventionNames":54},"33-45 years peri-menopausal","females aged 33-45 years (n=30)",{"label":66,"type":54,"description":67,"interventionNames":68},"46-59 years menopausal","females aged 46-59 years (n=30)",[69],"Other: Listerine mouthrinse",{"label":71,"type":54,"description":72,"interventionNames":73},"post-menopausal 60+years","females aged 60+years (n=30)",[69],[75],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":54},"Listerine mouthrinse","(iii) 46-59 years menopausal and (iv) post-menopausal 60+years will receive mouthwash for 7 days, with outcome measures recorded at 0 and 7 days (longitudinal)",[66,71],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":54,"email":84},"Zoe Brookes L Professor, PhD, BDS, Bsc","CONTACT","+44 1752 586828","zoe.brookes@plymouth.ac.uk",{"name":86,"role":82,"phone":54,"phoneExt":54,"email":87},"Laura Porritt","pdsexec@plymouth.ac.uk",[89],{"facility":90,"status":54,"city":91,"state":54,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Peninsula Dental School","Plymouth","PL4 8AA","United Kingdom","UK",{"type":96,"coordinates":97},"Point",[98,99],-4.14305,50.37153,{"lat":99,"lon":98},[102,104,108],{"name":103,"role":82,"phone":83,"phoneExt":54,"email":84},"Zoe L Brookes, Dr",{"name":105,"role":82,"phone":106,"phoneExt":54,"email":107},"Wai Ling Kok, Dr","+44 1752 583273","wailing.kok@plymouth.ac.uk",{"name":109,"role":110,"phone":54,"phoneExt":54,"email":54},"Amazon Doble, BSc, PhD","SUB_INVESTIGATOR",{"type":112,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"PRINCIPAL_INVESTIGATOR","Zoe Brookes","Professor of Translational Clinical Dentistry",[116],{"name":117,"class":118},"Kenvue Brands LLC","INDUSTRY","100659118","womens-health-screening-and-the-oral-microbiome-100659118",false,"NCT07859761","Womens Health Screening and the Oral Microbiome","Women's Health Screening and the Oral Microbiome: Improving Oral and Systemic Health During Menopause","Inclusion Criteria:\n\n* We will recruit female participants who are current Peninsula Dental School patients aged 18+, with any oral health status, including women taking the oral contraceptive pill and HRT, but this will be noted as confounding factors to be explored for association during this study. However, we only be able to recruit participants which have been female from birth and have not taken any transitioning hormones in their life.\n\nExclusion Criteria:\n\n* As this study focuses on the oral microbiome, salivary biomarkers alongside periodontal health, the following exclusion criteria will be applied, as they are known factors which influence the oral microbiome. These include existing diagnosis of diabetes (Type I or II), use of complete dentures, current immunosuppressant therapy, use of antimicrobial mouthwash within the past 3 months, being unfasted for 3 hours and consumption of predefined nitrate-rich foods within 48 hours before the appointment.",true,"FEMALE","18 Years",{"count":130,"type":131},240,"ESTIMATED","OBSERVATIONAL","The overall aims of this project are to undertake a women's health screening clinic on oral health and systemic health, linking the oral microbiome to hormonal status (menopause);\n\nThe follow quantitative and qualitative markers of oral health will be used:\n\n* Salivary and systemic female hormone status\n* Systemic\u002Fcardiovascular health markers, such as blood pressure, cholesterol and blood glucose\n* Clinical oral health variables (markers of plaque and gum disease)\n* Physiological and biochemical markers, such as salivary nitrate and nitrite\n* Oral microbiome\n* Breath analysis (volatile sulphur comounds)\n* Perceptions of mouth discomfort",[135,136,137,138],"Oral Health","Menopause","Gum Disease","Mouthwash",[140,141,142],"oral microbiome","womans health","menopause","NOT_YET_RECRUITING","2026-09-29",{"date":146,"type":147},"2026-10-06","ACTUAL",{"date":149,"type":131},"2026-10-01",{"date":151,"type":131},"2029-10-01",{"name":5,"class":6},1]