Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum

Modulation of Matrix Metalloproteinases-8, -9 and Endogenous Tissue Inhibitor-1 in Oral Biofluids During Pregnancy and Postpartum

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

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Saliva collection; Other: GCF collection

Detailed Description

MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. The balance between tissue inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the integrity of healthy periodontium.

• Study Type: Observational
• Enrollment (Actual): 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All women were systemically healthy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• (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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnancy group; Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)	Other: Saliva collection; Other: GCF collection
Postpartum group; Postpartum group included women, who were evaluated 6 months after giving birth	Other: Saliva collection; Other: GCF collection
Non-pregnant group; Women who were systemically healthy and non-pregnant.	Other: Saliva collection; Other: GCF collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): October 15, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: gingivitis; saliva; gingival crevicular fluid
• Other Study ID Numbers: BAP-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No