Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

July 31, 2018 updated by: Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

Evaluation of the Possible Relationship Between Preterm Labor 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
      • Rize, Turkey, 53000
        • Active, not recruiting
        • Recep Tayyip Erdogan University
      • İzmir, Turkey
        • Recruiting
        • Ege University Dentistry Faculty
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pınar Gumus, Dr.
      • İzmir, Turkey
        • Recruiting
        • İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
        • Contact:
  • United Kingdom
      • Glaskow, United Kingdom
        • Active, not recruiting
        • Glaskow Dental School , School of Medicine University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 30 years (Adult)

Accepts Healthy Volunteers

N/A

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 preterm labor between the age of 21 and 34. Control group consists of healthy females 24-36 6/7 weeks of pregnant with no history of preterm labor.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
preterm labor
Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34
Diagnostic test: preterm labor
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
Diagnostic test: healthy
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
healthy
24-36 6/7 weeks of pregnant between the age of 21 and 34
Diagnostic test: preterm labor
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
Diagnostic test: healthy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
prostaglandin E2
Time Frame: 1 Day
prostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
1 Day
TNF-Alpha
Time Frame: 1 day
TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
1 day
IL-1beta
Time Frame: 1 day
IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Porphyromonas gingivalis
Time Frame: 1 Day
Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None
1 Day
Tannerella Forsythia
Time Frame: 1 Day
Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Recep Tayyip Erdogan University Training and Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 40465587-26

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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