Womens Health Screening and the Oral Microbiome

ConditionsOral Health Menopause Gum Disease Mouthwash

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity of Plymouth

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Listerine mouthrinse
Other intervention
(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)

Treatment groups

240 Participants

are divided into 4 treatment groups

Group A: 18-32 years0 interventions

Group B: 33-45 years peri-menopausal0 interventions

Group C: 46-59 years menopausal1 intervention

Group D: post-menopausal 60+years1 intervention

Trial outcomes

Primary outcomes

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