Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorSaglik Bilimleri Universitesi

About this trial

Periodontal disease is a chronic inflammatory condition that affects the tissues supporting the teeth and may contribute to systemic inflammation and oxidative stress. Increasing evidence suggests that maternal inflammation during pregnancy may be associated with adverse pregnancy outcomes, including preterm birth. However, the biological mechanisms linking maternal periodontal inflammation to the intrauterine environment remain unclear.

This prospective observational cohort study aims to investigate the relationship between maternal periodontal status and inflammatory and oxidative stress biomarkers measured in both saliva and amniotic fluid. Eighty healthy pregnant women between 28 and 32 weeks of gestation will be recruited from the Obstetrics and Gynecology Clinic of Gulhane Training and Research Hospital. Participants will undergo a comprehensive periodontal examination and provide unstimulated saliva samples. Amniotic fluid samples will be collected during delivery as part of routine obstetric care, without any additional invasive procedures.

The concentrations of 8-hydroxy-2'-deoxyguanosine (8-OHdG), malondialdehyde (MDA), interleukin-6 (IL-6), and matrix metalloproteinase-8 (MMP-8) will be measured in saliva and amniotic fluid using enzyme-linked immunosorbent assay (ELISA). Pregnancy outcomes, including gestational age at delivery, birth weight, and pregnancy complications, will also be recorded.

The study will evaluate whether maternal periodontal inflammation is associated with changes in inflammatory and oxidative stress biomarkers in saliva and amniotic fluid and whether these biomarkers are related to pregnancy outcomes. The findings may improve understanding of the biological relationship between oral health and pregnancy and may contribute to the identification of biomarkers associated with adverse pregnancy outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women between 28 and 32 weeks of gestation

Age 18 to 40 years

Singleton pregnancy

Systemically healthy

Disqualifiers

Multiple pregnancy

Use of antibiotics or anti-inflammatory medications during pregnancy

Current smoking or alcohol consumption

Presence of an acute infection

Trial population

The study population consists of pregnant women aged 18-40 years with singleton pregnancies between 28 and 32 weeks of gestation who receive routine prenatal care at the Department of Obstetrics and Gynecology, Gülhane Training and Research Hospital. Participants will undergo periodontal examination and will be categorized according to periodontal status (with or without periodontitis) and pregnancy outcome (term or preterm delivery).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Pregnant Women Without Periodontitis
Group B: Pregnant Women With Periodontitis

Trial outcomes

Primary outcomes

1

Amniotic Fluid 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Level

Time frame
At delivery (approximately 5-12 weeks after enrollment)

Secondary outcomes

1

Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Level

Time frame
At enrollment (28-32 weeks of gestation)
2

Salivary and Amniotic Fluid Malondialdehyde (MDA) Levels

Time frame
At enrollment (saliva) and at delivery (amniotic fluid)
3

Salivary and Amniotic Fluid Interleukin-6 (IL-6) Levels

Time frame
At enrollment (saliva) and at delivery (amniotic fluid)
4

Salivary and Amniotic Fluid Matrix Metalloproteinase-8 (MMP-8) Levels

Time frame
At enrollment (saliva) and at delivery (amniotic fluid)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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