Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: Preeclampsia; Periodontal Disease
• Intervention / Treatment: Diagnostic test: preeclampsia; Diagnostic test: control

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53000
    • Active, not recruiting
    • Recep Tayyip Erdogan University Dentistry Faculty
  • Rize, Turkey, 53000
    • Active, not recruiting
    • Recep Tayyip Erdogan University Faculty of Medicine
  • İzmir, Turkey
    • Recruiting
    • Ege University Dentistry Faculty
    • Contact: : Nurcan Buduneli, Prof. Dr.; Phone Number: 05326962525; Email: nurcanbuduneli@yahoo.com
    • Contact: Önder Gürlek, Dr.; Phone Number: 05057555888; Email: dr.ondergurlek@hotmail.com
    • Sub-Investigator: Pınar Gumus, Dr.
  • İzmir, Turkey
    • Recruiting
    • İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
    • Contact: Murat Alan, Dr.; Phone Number: 05333952097; Email: gozdealan@hotmail.com
• United Kingdom
  • Glaskow, United Kingdom
    • Active, not recruiting
    • Glaskow Dental School , School of Medicine University of Glasgow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study is planned to be a case-control study. Workgroup consists of 50 patients which diagnosed with preeclampsia between the age of 18 and 40. Control group consists of healthy females over 37. weeks of pregnant with no history of preeclampsia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preeclampsia; 18-40 aged diagnosed with preeclampsia	Diagnostic test: preeclampsia; liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine; Other Names: blood sample, urine test; Diagnostic test: control; liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine; Other Names: blood sample, urine test
control; 18- 40 aged healthy females over 37. weeks of pregnant with no history of preeclampsia	Diagnostic test: preeclampsia; liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine; Other Names: blood sample, urine test; Diagnostic test: control; liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine; Other Names: blood sample, urine test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Collaborators: Ege University
• Investigators: Principal Investigator: Önder Gürlek, Dr., Ege University

Publications and helpful links

General Publications

• Jaiman G, Nayak PA, Sharma S, Nagpal K. Maternal periodontal disease and preeclampsia in Jaipur population. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):50-54. doi: 10.4103/jisp.jisp_363_15.

Helpful Links

• Maternal periodontal disease and preeclampsia in Jaipur population.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2018
• Primary Completion (Anticipated): September 17, 2018
• Study Completion (Anticipated): December 15, 2018

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Periodontal Diseases
• Other Study ID Numbers: 40465587-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available within 6 months of study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No