Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT07054177

Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease

Led by Bezmialem Vakif University · Updated on 2025-07-23

30

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Singleton pregnancy without complications for pregnant volunteers
  • Pregnancy confirmed by ultrasound
  • No history of pregnancy in the past 6 months for non-pregnant controls
  • Regular menstrual cycles for non-pregnant controls
  • No history of hormonal disorders for non-pregnant controls
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Bezmialem Vakıf University, Faculty of Dentistry and Faculty of Medicine, Istanbul

Istanbul, Fatih, Turkey (Türkiye), 34093

Actively Recruiting

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Research Team

C

Cansu Can Yasar, Periodontist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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