NCT02817568

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

June 27, 2016

Last Update Submit

June 29, 2016

Conditions

Keywords

Aggressive PeriodontitisC-C chemokine receptor 2Gene expressionmonocyte chemoattractant protein-1,restriction fragment length polymorphism

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (1)

  • MCP-1 gene expression in AgP patients

    six months

Study Arms (2)

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

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

Interventions

Drawing Blood for genetic analysis

Aggressive Periodontitis (case)Healthy (Control)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 14717852BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood of each subject is kept -80 celcius for further analysis.

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Abant Izzet Baysal University, Faculty of Dentistry

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2014

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Individual participant data is kept in private computer and all data can be shared if necessary