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

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ClinicalTrials.gov Identifier: NCT02927704
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
Selcuk University
Information provided by (Responsible Party):
Sadiye Gunpinar, Abant Izzet Baysal University

Brief Summary:
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.

Condition or disease Intervention/treatment
Aggressive Periodontitis Other: Gingival crevicular fluid (GCF) sample

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".

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 in Patients With Aggressive Periodontitis
Study Start Date : March 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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.




Primary Outcome Measures :
  1. Determination of GCF MCP-1 levels in patients with AgP [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Measurement of clinical periodontal parameters in patients with AgP and compare between LAgP and GAgP [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927704


Sponsors and Collaborators
Abant Izzet Baysal University
Selcuk University
Investigators
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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:

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Responsible Party: Sadiye Gunpinar, Abant Izzet Baysal University Faculty of Dentistry periodontology department, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT02927704    
Other Study ID Numbers: 2011/016
11102024 ( Other Grant/Funding Number: Selcuk University Scientific Foundation )
konya2013 ( Other Identifier: last day of the study )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sadiye Gunpinar, Abant Izzet Baysal University:
Aggressive Periodontitis
monocyte chemoattractant protein-1
gingival crevicular fluid
enzyme-linked immunosorbent assay
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms