NCT03449186

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

January 26, 2018

Last Update Submit

February 22, 2018

Conditions

Pregnancy

Keywords

periodontitispostpartum

Outcome Measures

Primary Outcomes (1)

  • Changing Il-17A levels

    Salivary and GCF level measured by ELISA

    6 month

Secondary Outcomes (3)

  • Changing IL-6 levels

    6 month

  • Changing IL-23 levels

    6 month

  • Changing IL-17E levels

    6 month

Study Arms (2)

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 collectionOther: 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 collectionOther: GCF collection

Interventions

Saliva collectionOTHER
Postpartum groupPregnancy group
GCF collectionOTHER
Postpartum groupPregnancy group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy women in second and third trimester
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All participants had 20 teeth present at least.

You may qualify if:

  • women 2 and 3 trimester of their pregnancy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 28, 2018

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

January 1, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02