Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

• Conditions: Preeclampsia; Periodontal Disease

• Registration Number: NCT03603236
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Brief Summary

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia.

The secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.

Detailed Description

Preeclampsia is identified as an important cause for mother and newborn mortality. Inspite of extensive research, the exact etiological relations have not been established.

Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. It is believed that the results will set light to the etiology of preeclampsia and will help to develop strategies to prevent the disease.

Study Timeline

• Study Start: 2018-02-17
• Status Verified: 2018-07
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2018-09-17
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• pregnant women with preeclampsia
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prostaglandin E2	1 Day	prostaglandin E2 levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
IL-1beta (Interleukin 1 beta)	1 day	IL-1beta levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
TNF-Alpha (Tumor necrosis factor -Alpha)	1 day	TNF-Alpha levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml

Secondary Outcome Measures

Name	Time	Method
Tannerella Forsythia	1 Day	Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None
Porphyromonas gingivalis	1 Day	Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None Tannerella Forsythia (+,-)

Trial Locations

Locations (5)

Ege University Dentistry Faculty; 🇹🇷 İzmir, Turkey

İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology; 🇹🇷 İzmir, Turkey

Recep Tayyip Erdogan University Dentistry Faculty; 🇹🇷 Rize, Turkey

Recep Tayyip Erdogan University Faculty of Medicine; 🇹🇷 Rize, Turkey

Glaskow Dental School , School of Medicine University of Glasgow; 🇬🇧 Glaskow, United Kingdom