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NCT07699978
Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers
Conditions: Periodontal Disease, Pregnancy, Preterm Birth
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Enrollment: 80
Sponsor: Saglik Bilimleri Universitesi
Summary
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
Inclusion Criteria:
* Pregnant women between 28 and 32 weeks of gestation
* Age 18 to 40 years
* Singleton pregnancy
* Systemically healthy
* Normal gestational diabetes screening (oral glucose tolerance test within the hospital reference range)
* Receiving only routine prenatal vitamin and iron supplementation (no therapeutic medications)
* Low-risk pregnancy
* No history of chorioamnionitis
* No periodontal treatment within the previous 6 months
* Able and willing to provide written informed consent
Exclusion Criteria:
* Multiple pregnancy
* Use of antibiotics or anti-inflammatory medications during pregnancy
* Current smoking or alcohol consumption
* Presence of an acute infection
* Placental pathology
* Major fetal anomaly
* High-risk pregnancy as determined by the obstetrician
* Refusal or inability to provide informed consent
Source: ClinicalTrials.gov (NCT07699978). StuddyBuddy aggregates publicly available trial information.