Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 (MCP-1)

October 6, 2016 updated by: Sadiye Gunpinar, Abant Izzet Baysal University

Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 in Patients With Aggressive Periodontitis

The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with aggressive periodontitis (AgP) are diagnosed as rapid and severe periodontal destruction commonly in younger systemically healthy individuals (Armitage, 1999). Although periopathogenic bacteria are essential for initiation, this alone does not be responsible for the manifestation and severity of the clinical status/phenotype (Offenbacher et al., 2008), suggesting an imbalance between host and bacterial load (Kinane et al., 2007). Response to bacterial biofilm is determined by the host immune system (Mahanonda and Pichyangkul, 2007, Amano, 2010) in which genetic and enviromental factors modify and may get individuals more susceptible or resistant to the periodontal diseases (Kulkarni and Kinane, 2014).

The role of whether an impaired or a hyperinflammatory host response is responsible for the progression of aggressive periodontitis has been a topic of discussion. Regarding to this topic Shaddox et al. (2016) studied the whole blood specimens collected from LAgP subjects and stimulated with plaque sample generated from healthy or diseased sites. And as a result, LAgP subjects displayed hyperinflammatory response regardless of contents of bacterial stimulus. In an another research hyperinflammatory responders LAgP subjects presented the lowest reductions in clinical parameters, on the contrary low responders showed the highest reductions after treatment (Allin et al., 2016). Similarly Garrison and Nichols (1989) reported that hyper-inflammatory monocyte phenotype can be deterministic in periodontal destruction. In the view of the aforementioned findings, the aim of this study is to estimate GCF MCP-1 levels of healthy and AgP subjects and to compare MCP-1 levels between LAgP and GAgP to establish its predictive value/role for distinguishing LAgP and GAgP development.

A total of 160 subjects including, 80 AgP and 80 age and gender matched periodontally healthy (H) controls were recruited in this cross-sectional study. Clinical periodontal measurements including plaque index (PI), gingival index (GI), proping depth (PD) and clinical attachment loss (CAL) were performed. GCF samples were collected from 160 patients including 50 LAgP, 30 GAgP and 80 H. Volume of GCF samples were measured by an electronic device (Periotron 8000, OroFlow Inc.) and GCF MCP-1 was measured by an enzyme-linked immunosorbent assay "ELISA".

Study Type

Observational

Enrollment (Actual)

160

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This cross-sectional case control study was carried out at Selcuk University, Faculty of Dentistry, Department of Periodontology. Aggressive periodontitis patients referred as case were diagnosed by single examiner.The control group included periodontally healthy volunteers from staff and other subjects referring to the School of Dentistry.

Description

Inclusion Criteria:

  • Periodontally Healthy control group (n: 80) had < 3mm PD, < 2 GI and no signs of interproximal attachment loss and a history of periodontal disease.
  • The AgP group included individuals diagnosed with localized AgP (LAgP) or generalized AgP (GAgP) who were otherwise healthy. Periodontal attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession not involving more than two permanent teeth, other than the first molars and incisors were diagnosed with LAgP (n: 50); patients with involvement of at least three teeth, other than the first molars and incisors with an attachment loss ≥4 mm accompanied by interproximal bone loss without gingival recession were diagnosed with GAgP (n: 30).

Exclusion Criteria:

  • Patients who have any systemic diseases or conditions that could effect the periodontium
  • hepatitis and/or immunodeficiency virus infection
  • a history of periodontal treatment and antibiotic therapy within the 6 months
  • < 16 teeth in their mouth
  • Subjects who had smoked and were ongoing orthodontic treatment were excluded.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case (Aggressive periodontitis)
Single intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention.
Other: Gingival crevicular fluid (GCF) sample
Single intervention has been performed for each subject. GCF samples were collected from four multi rooted teeth (premolar/molar) one of in each quadrant including two maxilla and two mandibula by single examiner in conjunction with clinical measurements in this intervention.
control (Periodontally healthy subjects)
Single intervention has been performed for each subject. Gingival crevicular fluid sample was obtained in conjunction with clinical measurements in this intervention.
Other: Gingival crevicular fluid (GCF) sample
Single intervention has been performed for each subject. GCF samples were collected from four multi rooted teeth (premolar/molar) one of in each quadrant including two maxilla and two mandibula by single examiner in conjunction with clinical measurements in this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of GCF MCP-1 levels in patients with AgP
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of clinical periodontal parameters in patients with AgP and compare between LAgP and GAgP
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Abant Izzet Baysal University

Collaborators

Selcuk University

Investigators

  • Principal Investigator: Sadiye Gunpinar, Asst. Prof., Abant Izzet Baysal University, Faculty of Dentistry, Periodontology Department
  • Principal Investigator: Nilgun O Alptekin, Prof., Baskent University, Faculty of Dentistry, Periodontology Department
  • Principal Investigator: Niyazi Dundar, Dr., Selcuk University, Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/016
  • 11102024 (Selcuk University Scientific Foundation)
  • konya2013 (Other Identifier: last day of the study)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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