Oral HealthNCT07859761
Womens Health Screening and the Oral Microbiome
An observational study of Oral Health and Menopause, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
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: Salivary and systemic female hormone status… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Menopause, Gum Disease
- What is being tested?
- Listerine mouthrinse
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Porritt contact
United Kingdom1 site
Peninsula Dental School
Plymouth, PL4 8AA
Zoe L Brookes, Dr, +44 1752 586828, zoe.brookes@plymouth.ac.uk
Wai Ling Kok, Dr, +44 1752 583273, wailing.kok@plymouth.ac.uk
About this study
Official title: Women's Health Screening and the Oral Microbiome: Improving Oral and Systemic Health During Menopause
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:
- Salivary and systemic female hormone status
- Systemic/cardiovascular health markers, such as blood pressure, cholesterol and blood glucose
- Clinical oral health variables (markers of plaque and gum disease)
- Physiological and biochemical markers, such as salivary nitrate and nitrite
- Oral microbiome
- Breath analysis (volatile sulphur comounds)
- Perceptions of mouth discomfort
Read the detailed description
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.
- Conditions
- Oral Health, Menopause, Gum Disease, Mouthwash
- Being tested
- Listerine mouthrinse
- Keywords
- oral microbiome, womans health, menopause
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine mouthrinseOther
(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)
| Study group | Role | What they receive |
|---|---|---|
| 18-32 years | females aged 18-32 years (n=30) | |
| 33-45 years peri-menopausal | females aged 33-45 years (n=30) | |
| 46-59 years menopausal | females aged 46-59 years (n=30) Receives: Other: Listerine mouthrinse | |
| post-menopausal 60+years | females aged 60+years (n=30) Receives: Other: Listerine mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oestrogen
Blood oestrogen from blood drawn from finger prick, at baseline screening appointment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Kenvue Brands LLC
- Responsible party
- Principal investigator, Zoe Brookes, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859761
- Sponsor's protocol ID
- 7432
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Muddiman KJ, Doble A, Stephen AS, Bescos R, Illsley CS, Nicholas TL, Hanks S, Toit LD, Brookes ZLS. A Pilot Study Assessing the Oral Microbiome in Women of Menopausal Age: Do Oral Nitrate-Reducing Bacteria Play a Role? Int Dent J. 2026 Jun;76(3):109518. doi: 10.1016/j.identj.2026.109518. Epub 2026 Mar 25.
PubMed 41889037
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Health Screening and the Oral Microbiome: Improving Oral and Systemic Health During Menopause
- ClinicalTrials.gov ID
- NCT07859761
- Acronym / sponsor ID
- 7432
- Conditions
- Oral Health, Menopause, Gum Disease, Mouthwash
- Keywords
- oral microbiome, womans health, menopause
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Kenvue Brands LLC
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Salivary and systemic female hormone status
- Systemic/cardiovascular health markers, such as blood pressure, cholesterol and blood glucose
- Clinical oral health variables (markers of plaque and gum disease)
- Physiological and biochemical markers, such as salivary nitrate and nitrite
- Oral microbiome
- Breath analysis (volatile sulphur comounds)
- Perceptions of mouth discomfort
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 18-32 years | – | –females aged 18-32 years (n=30) |
| 33-45 years peri-menopausal | – | –females aged 33-45 years (n=30) |
| 46-59 years menopausal | – | Other: Listerine mouthrinsefemales aged 46-59 years (n=30) |
| post-menopausal 60+years | – | Other: Listerine mouthrinsefemales aged 60+years (n=30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | 46-59 years menopausal, post-menopausal 60+years |
Primary outcome
Blood oestrogen
Time frame: Observational, 1 timepoint assessment. From October 2026 to July 2027.
Blood oestrogen from blood drawn from finger prick, at baseline screening appointment.
Blood pressure
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
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.
Oral bleeding
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral bleeding via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Volatile breath compounds
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
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.
Perception of oral soft tissue 'comfort'
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Dry mouth scoring system to be asked of the participants.
Oral plaque
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral plaque via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Probing pocket depth
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Probing pocket depth via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
BPE
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral BPE via BSP protocols at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Height
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Height at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Weight
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Weight at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Blood cholesterol
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Blood cholesterol at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
Blood glucose
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Blood glucose at baseline screening appointment. Intervention at day 1 and 7 days post intervention.
2 secondary outcomes
Saliva including ammonia, ph, buffering capcity, lactate, glucose, interleukins, nitrate, nitrite, and oral nitrate reducing capacity.
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Oral bacteria abundance
Time frame: Observational, 1 time point. Intervention 2 timepoints. From October 2026 to July 2027.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 41889037Muddiman KJ, Doble A, Stephen AS, Bescos R, Illsley CS, Nicholas TL, Hanks S, Toit LD, Brookes ZLS. A Pilot Study Assessing the Oral Microbiome in Women of Menopausal Age: Do Oral Nitrate-Reducing Bacteria Play a Role? Int Dent J. 2026 Jun;76(3):109518. doi: 10.1016/j.identj.2026.109518. Epub 2026 Mar 25.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Porritt contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Menopause, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Brookes L Professor, PhD, BDS, Bsc (+44 1752 586828, zoe.brookes@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oestrogen (time frame: Observational, 1 timepoint assessment. From October 2026 to July 2027.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07859761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.