Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers

NCT07699978 | Not Yet Recruiting

• 1 other identifier: 2026-202
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontal Disease; Pregnancy; Preterm Birth

Keywords

Periodontitis; Pregnancy; Preterm Birth; Oxidative Stress; Inflammation; Saliva; Amniotic Fluid; 8-Hydroxy-2'-deoxyguanosine (8-OHdG); Interleukin-6 (IL-6)

Outcome Measures

Primary Outcomes (1)

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

  At delivery (approximately 5-12 weeks after enrollment)

Secondary Outcomes (5)

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

  At enrollment (28-32 weeks of gestation)

• Salivary and Amniotic Fluid Malondialdehyde (MDA) Levels

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

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

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

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

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

• Correlation Between Salivary and Amniotic Fluid Biomarkers

  At delivery

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Periodontal Diseases; Premature Birth; Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erkan Özcan, Prof

CONTACT

+90 312 567 1500; erkan.ozcan@sbu.edu.tr

Sayna Behkar, Dr

CONTACT

+90 534 777 7430; saynabehkar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share