Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease

May 16, 2018 updated by: Veli Özgen Öztürk, Aydin Adnan Menderes University

Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants

The aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP-8 POC test in different periodontal health and disease and as compared to the established quantitative laboratory method (ELISA)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MMP-8 has been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. A positive aMMP-8 test could be an early indicator of these excessive and undesired tissue reactions.

Study Type

Observational

Enrollment (Actual)

103

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All participants have minimum 20 teeth

Description

Inclusion Criteria:

  • Systemically healthy
  • Nonsmokers

Exclusion Criteria:

  • Participants were not included if they had systemic disease such as diabetes, cardiovascular.
  • Participants who took regular medications that could affect of periodontal tissue
  • Participants who received antibiotics less than 10 weeks before the study

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
Chronic periodontitis
This groups participant has radiographically moderate alveolar bone loss, CAL > 5 mm and PD >6 mm in several sites of each quadrant
Diagnostic test: GCF collection with aMMP-8 chair side test
Other: Saliva collection
Generalized aggressive periodontitis
This demonstrated a generalized pattern of severe breakdown and CAL > 5 mm and PD > 6 mm on 8 > teeth; minimum three of those were other than first incisors or first molars
Diagnostic test: GCF collection with aMMP-8 chair side test
Other: Saliva collection
Gingivitis
This group has varying degrees of gingival inflammation, with CAL < 2 mm, without any radiographical bone loss due to periodontitis
Diagnostic test: GCF collection with aMMP-8 chair side test
Other: Saliva collection
Implant
Implants classified PD < 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss > 0.5 mm
Diagnostic test: GCF collection with aMMP-8 chair side test
Other: Saliva collection
Health
Probing depth (PD) < 3mm, no gingival recession due to periodontal disease, and clinical attachment level (CAL) < 2 mm, BOP in < 10% of full-mouth score examination
Diagnostic test: GCF collection with aMMP-8 chair side test
Other: Saliva collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aMMP-8 levels of GCF
Time Frame: 2 hours
GCF levels measured by IFMA
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary MMP-8 levels
Time Frame: 2 hours
Saliva levels measured by IFMA
2 hours

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes 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)

March 1, 2015

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 5, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP-17/1

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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