NCT02927704

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

October 6, 2016

Last Update Submit

October 6, 2016

Conditions

Aggressive Periodontitis

Keywords

Aggressive Periodontitismonocyte chemoattractant protein-1gingival crevicular fluidenzyme-linked immunosorbent assay

Outcome Measures

Primary Outcomes (1)

  • Determination of GCF MCP-1 levels in patients with AgP

    1 year

Secondary Outcomes (1)

  • Measurement of clinical periodontal parameters in patients with AgP and compare between LAgP and GAgP

    1 year

Study Arms (2)

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

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

Interventions

Gingival crevicular fluid (GCF) sampleOTHER

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.

case (Aggressive periodontitis)control (Periodontally healthy subjects)

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. 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.

You may qualify if:

  • 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).

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 (7)

  • 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

  • Lee E, Yang YH, Ho YP, Ho KY, Tsai CC. Potential role of vascular endothelial growth factor, interleukin-8 and monocyte chemoattractant protein-1 in periodontal diseases. Kaohsiung J Med Sci. 2003 Aug;19(8):406-15. doi: 10.1016/S1607-551X(09)70484-X.

    PMID: 12962428BACKGROUND

  • 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.

    PMID: 16274303BACKGROUND

  • Gupta M, Chaturvedi R, Jain A. Role of monocyte chemoattractant protein-1 (MCP-1) as an immune-diagnostic biomarker in the pathogenesis of chronic periodontal disease. Cytokine. 2013 Mar;61(3):892-7. doi: 10.1016/j.cyto.2012.12.012. Epub 2013 Jan 30.

    PMID: 23375122BACKGROUND

  • 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.

    PMID: 15367184BACKGROUND

  • Thunell DH, Tymkiw KD, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. A multiplex immunoassay demonstrates reductions in gingival crevicular fluid cytokines following initial periodontal therapy. J Periodontal Res. 2010 Feb;45(1):148-52. doi: 10.1111/j.1600-0765.2009.01204.x. Epub 2009 Jul 8.

    PMID: 19602112BACKGROUND

  • Tymkiw KD, Thunell DH, Johnson GK, Joly S, Burnell KK, Cavanaugh JE, Brogden KA, Guthmiller JM. Influence of smoking on gingival crevicular fluid cytokines in severe chronic periodontitis. J Clin Periodontol. 2011 Mar;38(3):219-28. doi: 10.1111/j.1600-051X.2010.01684.x. Epub 2010 Dec 29.

    PMID: 21198766BACKGROUND

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • 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

    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 periodontology department

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share