Generalized Aggressive PeriodontitisNCT02327533
Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis
An observational study of Generalized Aggressive Periodontitis, run by Kocaeli University.
Trial summary
In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Aggressive Periodontitis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Aggressive periodontitis patients: The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
Who may be able to join
- The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
Who cannot join
- Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or HIV infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than GAgP, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.
About this study
In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.
Read the detailed description
Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. Progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they have immunological abnormalities, which are thought to be under genetic control. However, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear.
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 AgP and generate further information other than clinical signs and symptoms of AgP.
The aim of this study was to identify gene-expression patterns of patients with generalized aggressive periodontitis by whole-transcriptome gene-expression analyses.
- Conditions
- Generalized Aggressive Periodontitis
- Keywords
- generalized aggressive periodontitis, microarray analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Aggressive Periodontitis | The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) | |
| Controls | Control subjects had no radiographic evidence of bone loss or any sign of past and present periodontitis. |
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)
Definition of gen networking and new molecular pathways
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 posted30 Dec 2014 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionDec 2014
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 Generalized Aggressive 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
- 60 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 Güzeldemir-Akçakanat, DDS, PhD, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327533
- Sponsor's protocol ID
- KOU KAEK2013/15
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kinane DF, Shiba H, Hart TC. The genetic basis of periodontitis. Periodontol 2000. 2005;39:91-117. doi: 10.1111/j.1600-0757.2005.00118.x. No abstract available.
PubMed 16135066Demmer 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 18980520Papapanou PN, Abron A, Verbitsky M, Picolos D, Yang J, Qin J, Fine JB, Pavlidis P. Gene expression signatures in chronic and aggressive periodontitis: a pilot study. Eur J Oral Sci. 2004 Jun;112(3):216-23. doi: 10.1111/j.1600-0722.2004.00124.x.
PubMed 15154918
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis
- ClinicalTrials.gov ID
- NCT02327533
- Acronym / sponsor ID
- KOU KAEK2013/15
- Conditions
- Generalized Aggressive Periodontitis
- Keywords
- generalized aggressive periodontitis, microarray analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Dec 2014 (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.
In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.
Detailed description
Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. Progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they have immunological abnormalities, which are thought to be under genetic control. However, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear.
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 AgP and generate further information other than clinical signs and symptoms of AgP.
The aim of this study was to identify gene-expression patterns of patients with generalized aggressive 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 Aggressive Periodontitis | – | –The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) |
| Controls | – | –Control subjects had no radiographic evidence of bone loss or any sign of past and present periodontitis. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Aggressive periodontitis patients: The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
Key inclusion criteria (1 listed)
- The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
Key exclusion criteria (1 listed)
- Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or HIV infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than GAgP, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRNA quantification
Time frame: 2 months
1 secondary outcome
Definition of gen networking and new molecular pathways
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 30 Dec 2014.
- Background: PubMed 16135066Kinane DF, Shiba H, Hart TC. The genetic basis of periodontitis. Periodontol 2000. 2005;39:91-117. doi: 10.1111/j.1600-0757.2005.00118.x. No abstract available.
- Results publication: 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.
- Results publication: PubMed 15154918Papapanou PN, Abron A, Verbitsky M, Picolos D, Yang J, Qin J, Fine JB, Pavlidis P. Gene expression signatures in chronic and aggressive periodontitis: a pilot study. Eur J Oral Sci. 2004 Jun;112(3):216-23. doi: 10.1111/j.1600-0722.2004.00124.x.
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 Güzeldemir-Akçakanat, DDS, PhD principal investigator
Kocaeli University
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Aggressive 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 1 inclusion and 1 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 Dec 2014. 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 NCT02327533, 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 30 Dec 2014.