An observational study in Oral Health, Menopause and Gum Disease, sponsored by University of Plymouth. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Plymouth · 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);
The follow quantitative and qualitative markers of oral health will be used:
During the menopause women are more likely to get dry mouth, burning mouth, gum disease and/or 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.
Oral 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.
We 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.
Finally, 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.
In 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.
84 studies on the registry are indexed under Gingival Diseases; 25 are open to participants now.
This study's planned enrollment of 240 is above the median of 108 across 17 observational studies indexed under Gingival Diseases.
Browse Gingival Diseases studies →University of Plymouth is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Female 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.
All patients who partake in this trial have a dentist/dental 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
Exclusion Criteria:
females aged 18-32 years (n=30)
females aged 33-45 years (n=30)
females aged 46-59 years (n=30)
Other: Listerine mouthrinse
females aged 60+years (n=30)
Other: 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)
Blood oestrogen
Blood oestrogen from blood drawn from finger prick, at baseline screening appointment.
Time frame: Observational, 1 timepoint assessment. From October 2026 to July 2027.
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.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral bleeding
Oral bleeding via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
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.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Perception of oral soft tissue 'comfort'
Dry mouth scoring system to be asked of the participants.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral plaque
Oral plaque via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Probing pocket depth
Probing pocket depth via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
BPE
Oral BPE via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Height
Height at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Weight
Weight at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Blood cholesterol
Blood cholesterol at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Blood glucose
Blood glucose at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
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.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral bacteria abundance
Oral microbiome analysis via either 16s or WGS techniques.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Plan to share: Yes — Anonymised data will be published and reported on in high impact quality journals and presented at international conferences. Oral microbiome data will also be uploaded to the appropriate Biobank(s) for data sharing purposes.
Supporting information: Study protocol, Sap, Icf, Csr
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Plymouth