How saliva metabolites change in pregnancy and gum disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.