NCT03516565

Brief Summary

The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 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

Typical duration 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

April 24, 2018

Last Update Submit

April 24, 2018

Conditions

Pregnancy

Keywords

gingivitissalivagingival crevicular fluid

Outcome Measures

Primary Outcomes (3)

  • Changing MMP-8 levels

    Salivary and GCF level measured by IFMA

    6 months

  • Changing MMP-9 levels

    Salivary and GCF level measured by ELISA

    6 months

  • Changing TIMP-1 levels

    Salivary and GCF level measured by ELISA

    6 months

Study Arms (3)

Pregnancy group

Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)

Other: Saliva collectionOther: GCF collection

Postpartum group

Postpartum group included women, who were evaluated 6 months after giving birth

Other: Saliva collectionOther: GCF collection

Non-pregnant group

Women who were systemically healthy and non-pregnant.

Other: Saliva collectionOther: GCF collection

Interventions

Saliva collectionOTHER
Non-pregnant groupPostpartum groupPregnancy group
GCF collectionOTHER
Non-pregnant groupPostpartum groupPregnancy group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All women were systemically healthy

You may qualify if:

  • Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)

You may not qualify if:

  • (a) any known systemic disease, (b) periodontal treatment within the last six months, (c) patients having less than 10 teeth, (d) smokers and (e) individuals with BMI \> 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 4, 2018

Study Start

April 1, 2013

Primary Completion

October 15, 2014

Study Completion

September 1, 2015

Last Updated

May 4, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share