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Aggressive PeriodontitisNCT02817568

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

An observational study of Aggressive Periodontitis, run by Abant Izzet Baysal University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Aggressive Periodontitis
What is being tested?
Drawing Blood
How many people
215 participants
Where
No sites listed yet
Study dates
Mar 2011to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

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

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)

Read the 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.

Being tested
Drawing Blood
Keywords
Aggressive Periodontitis, C-C chemokine receptor 2, Gene expression, monocyte chemoattractant protein-1,, restriction fragment length polymorphism
Medical subject headings
Aggressive Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drawing BloodOther

    Drawing Blood for genetic analysis

Study groups in NCT02817568
Study groupRoleWhat they receive
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)
Receives: Other: Drawing Blood
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)
Receives: Other: Drawing Blood

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of MCP-1 -2518 A/G and CCR2 -190 G/A gene polymorphisms in Aggressive Periodontitis

    Measured: one year

Secondary outcomes (1)
  1. MCP-1 gene expression in AgP patients

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2012
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817568
Sponsor's protocol ID
11102024
Other IDs
SU1985, SUPeriodontology
Status last verified
Jun 2016
First submitted
27 Jun 2016
Last updated
30 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual participant data is kept in private computer and all data can be shared if necessary

Publications

  • Armitage GC. Periodontal diagnoses and classification of periodontal diseases. Periodontol 2000. 2004;34:9-21. doi: 10.1046/j.0906-6713.2002.003421.x. No abstract available.

    PubMed 14717852
  • Yu X, Graves DT. Fibroblasts, mononuclear phagocytes, and endothelial cells express monocyte chemoattractant protein-1 (MCP-1) in inflamed human gingiva. J Periodontol. 1995 Jan;66(1):80-8. doi: 10.1902/jop.1995.66.1.80.

    PubMed 7891256
  • Zhu XL, Meng HX, Zhang L, Xu L, Chen ZB, Shi D, Feng XH, Zhang X. Association analysis between the -2518MCP-1(A/G) polymorphism and generalized aggressive periodontitis in a Chinese population. J Periodontal Res. 2012 Jun;47(3):286-92. doi: 10.1111/j.1600-0765.2011.01426.x. Epub 2011 Nov 27.

    PubMed 22117820
  • Pradeep AR, Daisy H, Hadge P. Gingival crevicular fluid levels of monocyte chemoattractant protein-1 in periodontal health and disease. Arch Oral Biol. 2009 May;54(5):503-9. doi: 10.1016/j.archoralbio.2009.02.007. Epub 2009 Mar 16.

    PubMed 19286166
  • Emingil G, Atilla G, Huseyinov A. Gingival crevicular fluid monocyte chemoattractant protein-1 and RANTES levels in patients with generalized aggressive periodontitis. J Clin Periodontol. 2004 Oct;31(10):829-34. doi: 10.1111/j.1600-051X.2004.00584.x.

    PubMed 15367184
  • Kurtis B, Tuter G, Serdar M, Akdemir P, Uygur C, Firatli E, Bal B. Gingival crevicular fluid levels of monocyte chemoattractant protein-1 and tumor necrosis factor-alpha in patients with chronic and aggressive periodontitis. J Periodontol. 2005 Nov;76(11):1849-55. doi: 10.1902/jop.2005.76.11.1849.

    PubMed 16274303

Questions about this trial

What is this clinical trial studying?

An observational study of Aggressive Periodontitis, run by Abant Izzet Baysal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of MCP-1 -2518 A/G and CCR2 -190 G/A gene polymorphisms in Aggressive Periodontitis (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817568, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.

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