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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Amniotic Fluid 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Level
Secondary outcomes
Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Level
Salivary and Amniotic Fluid Malondialdehyde (MDA) Levels
Salivary and Amniotic Fluid Interleukin-6 (IL-6) Levels
Salivary and Amniotic Fluid Matrix Metalloproteinase-8 (MMP-8) Levels
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: