Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorBezmialem Vakif University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Pregnant Women
Group B: Non-Pregnant Healthy Controls
Trial outcomes
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).
Time frame
Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartumSecondary outcomes
1
Bleeding on Probing (BOP)
Bleeding will be recorded at six sites per tooth using gentle probing. The outcome will be reported as the percentage of bleeding sites per participant.
Time frame
Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum2
Plaque Index score
Plaque accumulation will be assessed using the Silness-Löe Plaque Index (range: 0-3). The mean plaque index score per participant will be reported.
Time frame
Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartum3
Mean probing depth (PD)
Probing depth will be measured in millimeters (mm) at six sites per tooth. The average probing depth per participant will be reported.
Time frame
Baseline, 1st trimester (0-13 weeks), 2nd trimester (14-27 weeks), 3rd trimester (28 weeks and later), and 6-8 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov