Oral and Systemic aMMP-8 in Periodontal Disease

July 10, 2020 updated by: Zeynep Pinar KELES YUCEL, Aydin Adnan Menderes University

Local And Systemic Levels of aMMP-8 in Gingivitis and Stage 3 Periodontitis

Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aydın, Turkey
        • Aydin Adnan Menderes University

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with > 1 mm attachment loss, no radiographic sign of alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the teeth or more.They show also no more than 4 teeth loss due to periodontitis.

Description

Inclusion Criteria:

  • systemically healthy and non-smoker individuals aged 25 to 50 years
  • having ≥20 teeth present (except third molars)
  • individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses

Exclusion Criteria:

  • having any systemic disease
  • smoking
  • pregnancy or lactation
  • using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.

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
Healthy (n=23)
Other: Biochemical analysis
aMMP-8 is measured by immunofluorometric assay (IFMA).
Gingivitis (n=20)
Other: Biochemical analysis
aMMP-8 is measured by immunofluorometric assay (IFMA).
Periodontitis (n=40)
Other: Biochemical analysis
aMMP-8 is measured by immunofluorometric assay (IFMA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis
Time Frame: through study completion, an average of 4 months
aMMP-8 levels
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Collaborators

Giresun University

Investigators

  • Principal Investigator: Zeynep Pinar Keles Yucel, Department of Periodontology, School of Dentistry, Giresun University

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)

January 20, 2020

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2T/39

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

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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