Skip to content

Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03610841
Enrollment
100
Registered
2018-08-01
Start date
2018-02-17
Completion date
2018-12-15
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease, Preterm Labor

Brief summary

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor. The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.

Detailed description

Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.

Interventions

DIAGNOSTIC_TESTpreterm labor

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

DIAGNOSTIC_TESThealthy

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Sponsors

Ege University
CollaboratorOTHER
Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 34 Years

Inclusion criteria

* pregnant women with preterm labor * 37\. weeks of pregnant women with no history of preterm labor

Exclusion criteria

* Genitourinary infection * pregnancy or pre-pregnancy hypertension * HIV infection * diabetes mellitus * multiple pregnancy, preterm labor / low birth weight * smoker and alcohol use history * IVF pregnancy * placental, cervical and uterine anomalies * pregnancy with intrauterine growth retardation * pregnancies with congenital or chromosomal fetal anomalies * significant vaginal bleeding * infertility stories * drug addicts * poor socioeconomic level

Design outcomes

Primary

MeasureTime frameDescription
prostaglandin E21 Dayprostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
TNF-Alpha1 dayTNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
IL-1beta1 dayIL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml

Secondary

MeasureTime frameDescription
Tannerella Forsythia1 DayPresence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None
Porphyromonas gingivalis1 DayPresence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None

Countries

Turkey (Türkiye), United Kingdom

Contacts

Primary ContactGül Yıldız Telatar, Dr.
gulyildiz@gmail.com05365404555
Backup ContactBeril Gürlek, Dr.
berilsem@yahoo.com05535979403

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026