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Search / Trial NCT07054177

Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease

Launched by BEZMIALEM VAKIF UNIVERSITY · Jul 7, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Pregnancy Gingivitis Periodontal Disease Saliva Metabolomics Lc Ms/Ms

ClinConnect Summary

This clinical trial is studying how pregnancy affects the health of your gums and the tissues that hold your teeth in place. During pregnancy, hormone levels change a lot, which can make gums more sensitive, sometimes causing swelling, redness, or bleeding—this is called pregnancy gingivitis. The study will look at saliva samples from pregnant women at different stages of pregnancy and again a few weeks after giving birth, as well as from women who are not pregnant. By analyzing these samples, researchers hope to understand the natural changes in the mouth during pregnancy and how they might lead to gum problems. This could help doctors find better ways to detect and prevent gum issues in pregnant women.

Women between 18 and 40 years old can join if they are healthy, don’t smoke or drink alcohol, and haven’t used antibiotics or anti-inflammatory medicines recently. Pregnant participants should be having a single pregnancy without complications like diabetes or high blood pressure. Non-pregnant women in the study should have regular menstrual cycles and no recent pregnancies. If you join, you will provide saliva samples at different times during pregnancy and after delivery, or at similar times if you’re in the non-pregnant group. This study involves no treatment, just saliva collection, and your participation will help improve care for gum health during pregnancy in the future.

Gender

FEMALE

Eligibility 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

About Bezmialem Vakif University

Bezmialem Vakif University is a prominent academic institution based in Istanbul, Turkey, dedicated to advancing medical research and education. As a clinical trial sponsor, the university leverages its state-of-the-art facilities and a multidisciplinary team of experts to conduct innovative research that aims to improve patient outcomes and enhance therapeutic strategies. Bezmialem Vakif University is committed to adhering to rigorous ethical standards and regulatory guidelines, ensuring the integrity and reliability of its clinical trials while fostering collaboration with global research communities. Through its initiatives, the university seeks to contribute significantly to the field of medicine and public health.

Locations

Istanbul, Fatih, Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported