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RECRUITING
NCT07864220

Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion

Sponsor: Necmettin Erbakan University

View on ClinicalTrials.gov

Summary

This observational case-control study will investigate whether periodontal infection and inflammation are associated with missed abortion in pregnancies without detected major fetal chromosomal abnormalities. A total of 160 pregnant women aged 18 to 40 years and at 20 weeks of gestation or earlier are planned to be enrolled. The study will include 80 women diagnosed with missed abortion and 80 women with an ongoing uncomplicated pregnancy matched according to age and gestational week. Participants will undergo a clinical periodontal examination, and unstimulated saliva samples will be collected. Saliva will be analyzed for selected periodontal bacteria, including Porphyromonas gingivalis, Fusobacterium nucleatum, and Tannerella forsythia, as well as inflammatory biomarkers. Serum obtained from blood samples already collected as part of routine obstetric care will be used to measure inflammatory biomarkers, including IL-1β, IL-6, TNF-α, CRP, MMP-8, and prostaglandin E2. No additional blood sample will be collected solely for this study. Routine complete blood count results will also be used to calculate systemic inflammatory indices. For participants with missed abortion, study samples and periodontal assessments will be obtained after the diagnosis has been confirmed and before uterine evacuation or medical treatment. Routine fetal genetic test results will be reviewed, and cases with detected chromosomal abnormalities included in the clinical genetic assessment will be excluded from the main analysis. The study aims to determine whether periodontal pathogen burden, periodontal disease, and local and systemic inflammatory responses differ between women with missed abortion and women with ongoing uncomplicated pregnancies.

Official title: Salivary Periodontal Pathogen Burden and the Inflammatory-Prostaglandin E2 Axis in Missed Abortion Cases Without Fetal Chromosomal Abnormalities: A Case-Control Study

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-08-01

Completion Date

2027-06-15

Last Updated

2026-10-07

Healthy Volunteers

Yes

Locations (1)

Necmettin Erbakan University Faculty of Medicine, Department of Obstetrics and Gynecology

Konya, Konya, Turkey (Türkiye)