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Frequency Of MCP-1 And CCR2 Gene Polymorphisms And Its Effect On Gene Expression In Patients With AgP

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ClinicalTrials.gov Identifier: NCT02817568
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : June 30, 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 genetic impact of MCP-1 -2518 and its receptor CCR2 -190 polymorphisms on AgP patients among Turkish individuals and whether MCP-1 genotype effects mRNA levels of Peripheral Blood Mononuclear Cell Leukocyte (PBML)

Condition or disease Intervention/treatment
Aggressive Periodontitis Other: Drawing Blood

Detailed Description:

Differences in structure of gene or non genetic factors such as nutrition/environmental factors may alter functional gene product: mRNA/protein which play crucial roles in immune system. This can lead developing defective immune responses, exacerbation of current inflammation and increased host susceptibility to inflammatory diseases. Monocyte functions can be critical with regard to getting individuals susceptible to periodontitis. Similarly Garrison and Nichols (1989) reported that hyper-inflammatory monocyte phenotype can be deterministic in periodontal destruction. For this reason, regulation of MCP-1 and CCR2 expression, which have an essential role in defense system, may be a crucial step for managing inflammatory diseases as well as periodontitis.

Because of complex genetic nature of periodontal disease, we hypothesized that gene polymorphisms of MCP-1 and CCR2 could be associated with AgP and could alter the production of functional proteins, as a result might influence the susceptibility. Therefore, the primary aim of this study was to estimate genetic impact of MCP-1 and its receptor CCR2 polymorphisms on AgP patients among Turkish individuals and secondary outcome was whether MCP-1 genotype effects mRNA levels of PBML.

A total of 215 Turkish subjects from inner Anatolia including, 108 Aggressive periodontitis (AgP) and 107 age, gender and ethnic matched periodontally healthy (H) controls were recruited in this cross-sectional case control study. The control group included periodontally healthy volunteers from staff and other subjects referring to the School of Dentistry. The diagnosis of subjects were established on the basis of clinical and radiographic examination. Periodontally H control group (n:107) had <3mm probing Depth (PD), <2 gingival Index (GI) and no signs of interproximal attachment loss and a history of periodontal disease. Patients with AgP (n:108) were diagnosed by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions. The AgP group included individuals diagnosed with localized AgP (LAgP) or generalized AgP (GAgP) who were otherwise healthy. Periodontal attachment loss ≥4 mm not involving more than two permanent teeth, other than the first molars and incisors were diagnosed with LAgP (n: 43); patients with involvement of at least three teeth, other than the first molars and incisors with an attachment loss ≥4 mm were diagnosed with GAgP (n: 65) Genomic DNA was isolated from a peripheral blood sample obtained from each subject. Gene polymorphisms of MCP-1 -2518 A/G and CCR2 -190 G/A were analyzed by a standard polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) assay. Gene expression levels were quantified in peripheral blood leukocytes from 25 AgP and 15 periodontally H controls by quantitative real-time PCR. Threshold cycles (Ct ) values obtained from the RT-PCR analysis based on SYBR Green detection and data was normalized via ΔC t .

Sample size was determined by power analysis prior to study. According to this; an expected difference 20% in allele frequencies with 80% power, and % 95 confidence interval it was calculated that minimum of 102 patients were necessary in each group with a significance level of 0.05. ( ⃰ G. Power: 3.1.2). When comparing the numeric characteristics between H and AgP groups,non-parametric Mann-Whitney U test; between H, LAgP and GAgP groups then Kruskal Wallis with Bonferroni correction were calculated.

Deviations from Hardy-Weinberg equilibrium were assessed in the H and AgP groups based on genotype distribution for MCP-1 -2518 and CCR2 -190 by using a chi-squared test. The differences in genotype and allele frequencies between groups were also detected by the chi-square test. We used independent samples t-test for comparison of gene expression levels between groups and one way ANOVA was used to determine the effect of MCP-1 -2518 genotype on gene expression, based on log-transformed data. Significance level was P = 0.05.


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Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Evaluation of MCP-1 and CCR-2 Gene Polymorphisms Frequency and The Effects of This Polymorphism on Gene Expression in Patients With Aggressive Periodontitis
Study Start Date : March 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Aggressive Periodontitis (case)
Single intervention has been performed for each subject. Peripheral blood sample was obtained in conjunction with clinical measurements in this intervention.(Drawing Blood)
Other: Drawing Blood
Drawing Blood for genetic analysis

Healthy (Control)
Single intervention has been performed for each subject. Peripheral blood sample was obtained in conjunction with clinical measurements in this intervention. (Drawing Blood)
Other: Drawing Blood
Drawing Blood for genetic analysis




Primary Outcome Measures :
  1. Frequency of MCP-1 -2518 A/G and CCR2 -190 G/A gene polymorphisms in Aggressive Periodontitis [ Time Frame: one year ]

Secondary Outcome Measures :
  1. MCP-1 gene expression in AgP patients [ Time Frame: six months ]

Biospecimen Retention:   Samples With DNA
Peripheral Blood of each subject is kept -80 celcius for further analysis.


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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. The control group included periodontally healthy volunteers from staff and other subjects referring to the School of Dentistry.
Criteria

Inclusion Criteria:

  • Periodontally H control group 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 not involving more than two permanent teeth, other than the first molars and incisors were diagnosed with LAgP (n: 43); patients with involvement of at least three teeth, other than the first molars and incisors with an attachment loss ≥4 mm were diagnosed with GAgP

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): NCT02817568


Sponsors and Collaborators
Abant Izzet Baysal University
Selcuk University
Investigators
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Principal Investigator: Nilgun O Alptekin, Phd, DDS Baskent University, Faculty of Dentistry, Periodontology Department
Principal Investigator: Sadiye Gunpinar, Phd, DDS Abant Izzet Baysal University, Faculty of Dentistry, Periodontology Department
Principal Investigator: Hasan Acar, Phd Selcuk University, Faculty of Medicine, Department of Genetics
Principal Investigator: Vasfiye B Ucar, Phd Selcuk University, Faculty of Medicine, Department of Genetics

Publications of Results:
Other Publications:
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Responsible Party: Sadiye Gunpinar, Abant Izzet Baysal University, Faculty of Dentistry, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT02817568     History of Changes
Other Study ID Numbers: 11102024
SU1985 ( Other Identifier: SelcukUniversity )
SUPeriodontology ( Other Identifier: SelcukUniversity )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is kept in private computer and all data can be shared if necessary

Keywords provided by Sadiye Gunpinar, Abant Izzet Baysal University:
Aggressive Periodontitis
C-C chemokine receptor 2
Gene expression
monocyte chemoattractant protein-1,
restriction fragment length polymorphism

Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms