Th17 Inducing Cytokines Pregnancy and After Postpartum | NCT03449186

Studies
Th17 Inducing Cytokines Pregnancy and After Postpartum

NCT03449186

Sponsor

Aydin Adnan Menderes University

Status

Completed

Last Update Posted

Feb 28, 2018Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Saliva collection
GCF collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2013Actual

Primary Completion Date

Apr 2014Actual

Completion Date

Jan 2018Actual

First Submitted Date

Jan 26, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2018

Last Update Posted Date

Feb 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veli Özgen Öztürk, Principal Investigator, Aydin Adnan Menderes UniversityPrincipal Investigator

Lead Sponsor

Aydin Adnan Menderes UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Saliva collection Other: GCF collection
Postpartum group		Postpartum women 6 months after giving birth recalled. Saliva and GCF samples were collected and clinical periodontal measurements were made.	Other: Saliva collection Other: GCF collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saliva collection	Other		Postpartum group Pregnancy group
GCF collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changing Il-17A levels	Salivary and GCF level measured by ELISA	6 month

Secondary Outcomes

Measure	Description	Time Frame
Changing IL-6 levels	Salivary and GCF level measured by ELISA	6 month
Changing IL-23 levels	Salivary and GCF level measured by ELISA

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnancy women in second and third trimester

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

All participants had 20 teeth present at least.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided