Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers

Sponsor
Saglik Bilimleri Universitesi
Study ID
NCT07699978
Status
Not Yet Recruiting

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Conditions

  • Periodontal Disease
  • Pregnancy
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Aug 20, 2026
Status verified
Jun 2026
Primary completion
Mar 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Pregnant Women Without Periodontitis
    Pregnant women aged 18-40 years with singleton pregnancies between 28 and 32 weeks of gestation who do not have periodontitis. This cohort includes periodontally healthy participants and participants with gingivitis who do not meet the diagnostic criteria for periodontitis according to the 2017 World Workshop Classification.
  • Arm: Pregnant Women With Periodontitis
    Pregnant women aged 18-40 years with singleton pregnancies between 28 and 32 weeks of gestation who are diagnosed with periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.

Primary Outcome Measure

Amniotic Fluid 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Level [ Time Frame: At delivery (approximately 5-12 weeks after enrollment) ]

Central Contacts

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