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Status unknownNCT03603236Updated Jul 27, 2018

Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

An observational study in Preeclampsia and Periodontal Disease, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Status unknown at 5 sites in 2 countries. Open to female participants aged 21 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
21 Years to 34 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Preeclampsia
  • Periodontal Disease
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 34 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • pregnant women with preeclampsia
    1. weeks of pregnant women with no history of preterm labor

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • preeclampsia

    18-40 aged diagnosed with preeclampsia

    Diagnostic Test: preeclampsia · Diagnostic Test: control

  • control

    18- 40 aged healthy females over 37. weeks of pregnant with no history of preeclampsia

    Diagnostic Test: preeclampsia · Diagnostic Test: control

Interventions

  • Diagnostic testpreeclampsia

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

    Also known as: blood sample, urine test

  • Diagnostic testcontrol

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

    Also known as: blood sample, urine test

06

What researchers measure

Primary outcomes

  1. prostaglandin E2

    prostaglandin E2 levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml

    Time frame: 1 Day

  2. 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

    Time frame: 1 day

  3. 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

    Time frame: 1 day

Secondary outcomes

  1. Porphyromonas gingivalis

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

    Time frame: 1 Day

  2. Tannerella Forsythia

    Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None

    Time frame: 1 Day

07

Study locations

2 of 5 sites recruiting
  • Ege University Dentistry Faculty
    İzmir, Turkey
    Recruiting
  • İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
    İzmir, Turkey
    Recruiting
  • Recep Tayyip Erdogan University Dentistry Faculty
    Rize, 53000, Turkey
    Active, not recruiting
  • Recep Tayyip Erdogan University Faculty of Medicine
    Rize, 53000, Turkey
    Active, not recruiting
  • Glaskow Dental School , School of Medicine University of Glasgow
    Glaskow, United Kingdom
    Active, not recruiting
08

References and documents

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. PubMed 29568173 ↗

Individual participant data

Plan to share: No — Data will be available within 6 months of study completion

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03603236
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Ege University
Responsible party
Gul Yildiz Telatar (Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jul 27, 2018
Start date
Feb 17, 2018
Primary completion
Sep 17, 2018 (estimated)
Completion
Dec 15, 2018 (estimated)
Last update
Jul 27, 2018

Study contacts

Gül Yıldız Telatar, Dr.
Contact
gulyildiz@gmail.com
05365404555
Beril Gürlek, Dr.
Contact
berilsem@yahoo.com
05535979403
Gül Yıldız Telatar
principal investigator · Recep Tayyip Erdogan University Dentistry Faculty
Önder Gürlek, Dr.
principal investigator · Ege University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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