NCT02467283

Brief Summary

Current concepts of the causes of periodontitis implicate a bacterial infection as the primary cause of the disease. Several bacterial species residing in a biofilm on tooth surfaces are closely associated with periodontitis. Chronic periodontitis (CP) is initiated and sustained by bacterial plaque, but host defense mechanisms play an integral role in its pathogenesis. Gene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. Gene expression profiling may provide an evidence for involving genes in the pathogenesis of CP and generate further information other than clinical signs and symptoms of CP. The aim of this study was to identify gene-expression patterns of patients with chronic periodontitis by whole-transcriptome gene-expression analyses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 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

February 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

June 3, 2015

Last Update Submit

February 9, 2018

Conditions

Chronic Periodontitis

Keywords

chronic periodontitisgeneticsmicroarray analysisgingivagenesinflammation

Outcome Measures

Primary Outcomes (1)

  • mRNA quantification

    2 months

Secondary Outcomes (1)

  • Gen networking map

    2 months

Study Arms (2)

Patients with Chronic Periodontitis

All subjects were free of systemic diseases and to be included, individuals had to be older than 18 years of age. Chronic periodontitis was diagnosed according to American Academy of Periodontology 1999 Consensus Report.

Genetic: Genom-based whole-genome transcriptomic

Control Patients

Control subjects had no radiographic evidence of bone loss or any sign of past and present periodontitis. All subjects were free of systemic diseases and to be included, individuals had to be older than 18 years of age.

Genetic: Genom-based whole-genome transcriptomic

Interventions

Genom-based whole-genome transcriptomicGENETIC

Gene expression profiling is a powerful means of generating comprehensive genome-level data sets.

Control PatientsPatients with Chronic Periodontitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patientswere recruited from those patients seeking dental treatment in Kocaeli University, Faculty of Dentistry Periodontology Clinics.

You may qualify if:

  • CP patients had at least 20 teeth exhibiting \>30% of measured sites with \>5mm clinical attachment loss.
  • Had bleeding on probing (BOP) at \>50% of the proximal sites.

You may not qualify if:

  • Had any known systemic diseases that can influence the periodontal status, oral diseases other than chronic periodontitis and ongoing orthodontic therapy.
  • History of hepatitis, HIV infection, or diabetes; requirement for antibiotic prophylaxis, pregnancy or lactation; and long-term use of anti-inflammatory drugs.
  • Should be free of systemic diseases
  • Individuals had to be older than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.

    PMID: 10863370BACKGROUND

  • Demmer RT, Behle JH, Wolf DL, Handfield M, Kebschull M, Celenti R, Pavlidis P, Papapanou PN. Transcriptomes in healthy and diseased gingival tissues. J Periodontol. 2008 Nov;79(11):2112-24. doi: 10.1902/jop.2008.080139.

    PMID: 18980520BACKGROUND

  • Savli H, Sunnetci D, Cine N, Gluzman DF, Zavelevich MP, Sklyarenko LM, Nadgornaya VA, Koval SV. Gene expression profiling of B-CLL in Ukrainian patients in post-Chernobyl period. Exp Oncol. 2012;34(1):57-63.

    PMID: 22453151BACKGROUND

MeSH Terms

Conditions

Chronic PeriodontitisInflammation

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Esra Guzeldemir-Akcakanat, DDS, PhD

    Chair and Associate Professor of Dept. of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

February 1, 2013

Primary Completion

August 1, 2015

Study Completion

May 1, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share