- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03449186
Th17 Inducing Cytokines Pregnancy and After Postpartum
February 22, 2018 updated by: Veli Özgen Öztürk, Aydin Adnan Menderes University
Interleukin-17 and Th17 Inducing Cytokines Exacerbate Periodontal Disease During Pregnancy and Postpartum
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
IL-17 have a synergytic effect with IL-6 and IL-23.
IL-17A levels elevated with periodontal diseases.
Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.
Study Type
Observational
Enrollment (Actual)
114
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
Ages Eligible for Study
19 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
All participants had 20 teeth present at least.
Description
Inclusion Criteria:
- women 2 and 3 trimester of their pregnancy
Exclusion Criteria:
- any known systemic disease,
- periodontal treatment within the last six months,
- patients having less than 10 teeth,
- smokers,
- individuals with a BMI > 30 kg/m2,
- gestational diabetes and preeclampsia during pregnancy.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnancy group
Women, who were in their second trimester (weeks 16-24) or third trimester (weeks 25-34)selected for the study.
Saliva and GCF samples were collected and clinical periodontal measurements were made gently
|
|
Postpartum group
Postpartum women 6 months after giving birth recalled.
Saliva and GCF samples were collected and clinical periodontal measurements were made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changing Il-17A levels
Time Frame: 6 month
|
Salivary and GCF level measured by ELISA
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changing IL-6 levels
Time Frame: 6 month
|
Salivary and GCF level measured by ELISA
|
6 month
|
Changing IL-23 levels
Time Frame: 6 month
|
Salivary and GCF level measured by ELISA
|
6 month
|
Changing IL-17E levels
Time Frame: 6 month
|
Salivary and GCF level measured by ELISA
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
January 26, 2018
First Submitted That Met QC Criteria
February 22, 2018
First Posted (Actual)
February 28, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BAP-2015
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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