NCT07054177 Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease
| NCT ID | NCT07054177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bezmialem Vakif University |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-06-24 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to better understand how pregnancy affects the health of the gums and tissues that support the teeth. During pregnancy, hormone levels (like estrogen and progesterone) increase significantly. These hormonal changes can cause many changes in the body, including in the mouth. Some pregnant women may notice that their gums become swollen, red, or bleed more easily - this is called pregnancy gingivitis. It happens more often during the second and third trimesters and usually improves after birth. Even if a pregnant person has good oral hygiene, hormonal changes may still make the gums more sensitive to plaque and bacteria. Scientists believe that these changes in gum health are linked to how the body responds to hormones, bacteria in the mouth, and changes in the immune system. To explore this further, saliva samples will be collected from: * Pregnant women during their 1st, 2nd, and 3rd trimesters * The same women again 6-8 weeks after giving birth * A group of non-pregnant, healthy women as a comparison group The investigators will use a scientific method called untargeted metabolomics to study these saliva samples. This method helps looking at small substances (called metabolites) in saliva to see if there are any patterns related to pregnancy and gum health. The goal is to identify biological changes that happen during pregnancy and understand how they might affect the gums. This research will help improve early detection and prevention of gum problems during pregnancy in the future.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07054177 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054177 currently recruiting?
Yes, NCT07054177 is actively recruiting participants. Contact the research team at cansu.ysr@gmail.com for enrollment information.
Where is the NCT07054177 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07054177 clinical trial?
NCT07054177 is sponsored by Bezmialem Vakif University. The trial plans to enroll 30 participants.