Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603236
• Other study ID #: 40465587-28
• Status: Recruiting
• Start date: February 17, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: July 2018
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Gül Yildiz Telatar, Dr.
• Phone: 05365404555
• Email: gulyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Pre-Eclampsia
• Preeclampsia

Intervention

Diagnostic Test:
• preeclampsia
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
• control
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Locations

Country	Name	City	State
Turkey	Ege University Dentistry Faculty	Izmir
Turkey	Izmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology	Izmir
Turkey	Recep Tayyip Erdogan University Dentistry Faculty	Rize
Turkey	Recep Tayyip Erdogan University Faculty of Medicine	Rize
United Kingdom	Glaskow Dental School , School of Medicine University of Glasgow	Glaskow

Sponsors (2)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital	Ege University

Countries where clinical trial is conducted

Turkey,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Porphyromonas gingivalis	Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None Tannerella Forsythia (+,-)	1 Day
Secondary	Tannerella Forsythia	Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None	1 Day

External Links

•   Maternal periodontal disease and preeclampsia in Jaipur population.