How saliva metabolites change in pregnancy and gum disease
Salivary Metabolomics of Pregnancy and Periodontal Disease Related Metabolic Pathways
This project will test whether saliva metabolites change across pregnancy and after birth by comparing pregnant people to non‑pregnant volunteers to learn how hormonal shifts relate to gum inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07054177 on ClinicalTrials.gov |
What this trial studies
Researchers will collect saliva samples from 15 pregnant volunteers in the 1st, 2nd, and 3rd trimesters and again 6–8 weeks after delivery, plus samples from a matched group of non‑pregnant healthy controls. Clinical periodontal status will be recorded alongside sample collection to link metabolic signals with gum health. Samples will be analyzed using untargeted LC‑MS/MS metabolomics to identify metabolites and pathways associated with pregnancy‑related hormonal changes and periodontal changes. The study is single‑center and longitudinal but relatively small, intended to generate hypotheses and candidate biomarkers for further work.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant people aged 18–40 with a singleton, uncomplicated pregnancy and non‑pregnant healthy volunteers who meet the listed inclusion criteria.
Not a fit: People with systemic disease, BMI over 30, recent antibiotic or anti‑inflammatory use, smoking or alcohol use, or complicated pregnancies are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could identify saliva markers that help explain or predict pregnancy gingivitis and guide targeted prevention or monitoring.
How similar studies have performed: Previous research has shown pregnancy alters oral microbiota and some saliva biomarkers, but untargeted saliva metabolomics in this specific pregnancy–periodontal context is relatively exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 40 years * No history of systemic disease or chronic infection * No use of antibiotics or anti-inflammatory drugs in the last 3 months * Non-smoker and non-alcohol user * Willingness to participate by signing the informed consent form Additional Criteria for Pregnant Volunteers: * Singleton pregnancy (no multiple gestation) * Pregnancy progressing without complications (e.g., no diagnosis of preeclampsia, gestational diabetes, or threatened preterm labor) * Gestational age confirmed by ultrasound Additional Criteria for Non-Pregnant Control Group: * No history of pregnancy in the past 6 months * Regular menstrual cycles * No history of hormonal disorders (e.g., polycystic ovary syndrome, thyroid dysfunction) Exclusion Criteria: * Use of anti-inflammatory or antimicrobial treatments in the past 3 months * Smoking or alcohol consumption * Body mass index (BMI) \> 30 kg/m² * Presence of systemic diseases including diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid dysfunction, Cushing's syndrome, hypertension, liver or kidney dysfunction * Use of medications that may affect metabolic or hormonal parameters, such as oral contraceptives, steroid hormones, antihypertensives, or insulin-sensitizing drugs * Periodontal treatment in the past 6 months * Use of medications known to affect periodontal status (e.g., phenytoin, calcium channel blockers, cyclosporine, warfarin, NSAIDs, aspirin \> 81 mg) * Active infectious diseases such as hepatitis, HIV, or tuberculosis
Where this trial is running
Istanbul, Fatih
- Bezmialem Vakıf University, Faculty of Dentistry and Faculty of Medicine, Istanbul — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Cansu Can Yasar, Periodontist
- Email: cansu.ysr@gmail.com
- Phone: +905453153495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.