Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease

NCT07054177 | Recruiting

• 1 other identifier: E195935
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Gingivitis and Periodontal Diseases

Keywords

pregnancy; gingivitis; periodontal disease; saliva; metabolomics; LC-MS/MS

Outcome Measures

Primary Outcomes (1)

• Salivary Metabolite Profile by Pregnancy Status

  Untargeted metabolomic analysis of saliva samples will be performed using LC-MS/MS to identify metabolite patterns associated with different stages of pregnancy and periodontal status. Results will be reported as relative metabolite concentrations (normalized intensity, arbitrary units).

  Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum

Secondary Outcomes (3)

• Bleeding on Probing (BOP)

  Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum

• Plaque Index score

  Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum

• Mean probing depth (PD)

  Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum

Study Arms (2)

Pregnant Women

This group includes 15 healthy pregnant women aged 18-40 with uncomplicated pregnancies. Saliva samples are collected at four time points: during the first (0-13 weeks), second (14-27 weeks), and third trimesters (28 weeks and later), and at 6-8 weeks postpartum. No medical intervention is applied. The aim is to analyze changes in periodontal parameters and salivary metabolite profiles over time using untargeted metabolomics via LC-MS/MS.

Non-Pregnant Healthy Controls

This group includes 15 systemically healthy, non-pregnant women aged 18-40 with regular menstrual cycles and no history of pregnancy in the past 6 months. Saliva and periodontal measurements are collected during the early follicular phase of the menstrual cycle. These participants serve as the control group for comparative evaluation of salivary metabolomic profiles and periodontal health status.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only individuals assigned female at birth are eligible to participate, as the study focuses on pregnancy and related hormonal and periodontal changes.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes systemically healthy pregnant women in different trimesters and postpartum period, and non-pregnant healthy women aged 18-40 years attending routine gynecology or periodontology clinics.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

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

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples will be collected from all participants during different stages of pregnancy (first, second, and third trimesters, and 6-8 weeks postpartum) and from non-pregnant healthy controls. The samples will be centrifuged and stored at -80°C until analysis. The retained specimens will be used solely for untargeted metabolomic analysis using LC-MS/MS. No DNA extraction or genetic testing will be performed.

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Cansu Can Yasar, Periodontist

CONTACT

+905453153495; cansu.ysr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 8, 2025
• Study Start: June 24, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

TU (1)