Chronic PeriodontitisNCT02467283
Gene Expression Profiles in Chronic Periodontitis
An observational study of Chronic Periodontitis, run by Kocaeli University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Genom-based whole-genome transcriptomic
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patientswere recruited from those patients seeking dental treatment in Kocaeli University, Faculty of Dentistry Periodontology Clinics.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Gene Expression Profiles in Chronic Periodontitis: A Gene Network-based Microarray Analysis
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.
- Conditions
- Chronic Periodontitis
- Being tested
- Genom-based whole-genome transcriptomic
- Keywords
- chronic periodontitis, genetics, microarray analysis, gingiva, genes, inflammation
- Medical subject headings
- Chronic Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genom-based whole-genome transcriptomicGenetic
Gene expression profiling is a powerful means of generating comprehensive genome-level data sets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Genom-based whole-genome transcriptomic |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA quantification
Measured: 2 months
Secondary outcomes (1)
Gen networking map
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Guzeldemir-Akcakanat, Kocaeli University
- Investigators
- Esra Guzeldemir-Akcakanat, DDS, PhD, Principal investigator, Chair and Associate Professor of Dept. of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467283
- Sponsor's protocol ID
- KOU KAEK 2013 / 15
- Status last verified
- Feb 2018
- First submitted
- 3 Jun 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 10863370Demmer 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.
PubMed 18980520Savli 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.
PubMed 22453151
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiles in Chronic Periodontitis: A Gene Network-based Microarray Analysis
- ClinicalTrials.gov ID
- NCT02467283
- Acronym / sponsor ID
- KOU KAEK 2013 / 15
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis, genetics, microarray analysis, gingiva, genes, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Periodontitis | – | Genetic: Genom-based whole-genome transcriptomicAll 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. |
| Control Patients | – | Genetic: Genom-based whole-genome transcriptomicControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patientswere recruited from those patients seeking dental treatment in Kocaeli University, Faculty of Dentistry Periodontology Clinics.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genom-based whole-genome transcriptomicGene expression profiling is a powerful means of generating comprehensive genome-level data sets. | Genetic | Control Patients, Patients with Chronic Periodontitis |
Primary outcome
mRNA quantification
Time frame: 2 months
1 secondary outcome
Gen networking map
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 10863370Armitage 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.
- Background: PubMed 18980520Demmer 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.
- Background: PubMed 22453151Savli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Guzeldemir-Akcakanat, DDS, PhD principal investigator
Chair and Associate Professor of Dept. of Periodontology
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis, run by Kocaeli 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 4 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 12 Feb 2018. 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?
mRNA quantification (time frame: 2 months). 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 NCT02467283, which also lists 3 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 12 Feb 2018.