Generalized Aggressive PeriodontitisNCT04026828
Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
An observational study of Generalized Aggressive Periodontitis and Chronic Periodontitis, run by Kocaeli University.
Trial summary
Generalized aggressive Periodontitis (GAgP) and chronic periodontitis (CP) are inflammatory diseases. Little is known about molecular changes and signaling cascade of host response. Inflammatory diseases are undercontrol of genetic and enviromental factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Generalized Aggressive Periodontitis, Chronic Periodontitis
- What is being tested?
- Periodontitis Group
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 15 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Having aggressive or chronic periodontitis and healthy volenteers
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),
- Between 18 and 35 years of age,
- Otherwise healthy,
- The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
- 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.
- Overall healthy individuals (dental, periodontal and systemically)
Who cannot join
- 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,
- Had oral diseases other than GAgP,
- Oongoing orthodontic therapy,
- A history of antibiotic therapy, or periodontal treatment within the preceding six months
Trial locations and contacts
No sites are listed yet.
About this study
Generalized aggressive Periodontitis (GAgP) and chronic periodontitis (CP) are inflammatory diseases. Little is known about molecular changes and signaling cascade of host response. Inflammatory diseases are undercontrol of genetic and enviromental factors. Transcription factors are gene-specific factors that are often considered to act as a link connecting genetic and enviromental factors.
The aim of this study is to investigate the gene regions that are thought to play a role in the pathogenesis of GAgP and CP, and to interpret new and reliable pathognomonic-prognostic markers in the diagnosis and treatment of these diseases with the help of expression and mutation analyzes and polymorphism studies.
Read the detailed description
Generalized aggressive Periodontitis (GAgP) is a multifactorial, destructive, inflammatory and complex disease. The progression of the disease is undercontrol of immunologic, microbiologic, environmental and genetic factors. The immunologic and genetic factors are not clearly defined yet.
Chronic periodontitis (CP) is an infectious disease resulting within the supporting tissues of the teeth. It is commonly detected in adults. CP is initiated and sustained by bacterial plaque.
Both AgP and CP are inflammatory diseases. Little is known about molecular changes and signaling cascade of host response. Inflammatory diseases are undercontrol of genetic and environmental factors. Transcription factors are gene-specific factors that are often considered to act as a link connecting genetic and environmental factors.
This research is a continuation project. In the previous 2 studies which were conducted and published with the support of TÜBİTAK 1001 and KOU BAP, it was found 2 gene regions thought to have an effect on GAgP and KP pathogenesis by genomics, proteomics and immunohistochemical methods; MZB1 and ECH1. The aim of this study is to confirm these gene regions by gene expression analysis, mutation analysis and polymorphism studies.
In the literature, there was no study on the genome analysis, protein activity and immunohistochemical examination of these genes in the CP and GAgP. There was no study that evaluated the expression, mutation and polymorphism studies.
The first 2 steps of the study were completed with the support provided by Kocaeli University Scientific Research Project Unit [119.500,00 TL (KOU BAP 2013/5)] and TUBITAK [(TÜBİTAK 1001 214S008, 261.500,00 TL)].
The aim of this study is to investigate the gene regions that are thought to play a role in the pathogenesis of GAgP and CP, and to interpret new and reliable pathognomonic-prognostic markers in the diagnosis and treatment of these diseases with the help of expression and mutation analyzes and polymorphism studies. Gene sites identified and clinically relevant in this study will serve as the basis for another study in which these genes are aimed at silencing.,,,
This research is a continuation project. In the previous 2 studies which were conducted and published with the support of TÜBİTAK 1001 and KOU BAP, it was found 2 gene regions that concluded which may have an effect on GAgP and KP pathogenesis by genomics, proteomics and immunohistochemical methods; MZB1 and ECH1. The aim of this study is to confirm these gene regions by gene expression analysis, mutation analysis and polymorphism studies.
- Being tested
- Periodontitis Group
- Keywords
- chronic periodontitis, aggressive periodontitis, expression, polymorphism, mutation
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontitis GroupGenetic
Periodontitis group consists of both chronic and aggressive periodontitis patients
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Chronic periodontitis and aggressive periodontitis patients Receives: Genetic: Periodontitis Group | |
| Control Group | Both periodontal and medically healthy volunteers. Receives: Genetic: Periodontitis Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and accuracy of the products of RNA and DNA
RNA and DNA will be isolated from cells and the quality and accuracy of the products will be tested by Agilent 2100 bioanalyzer chips and quatity of the products will be controlled by Nanodrop ND 1000 spectrophotometer.
Measured: 6 months
Mutations Analysis
Evaluation will be performed with DNA which extracted from tissues. Amplicons will be reproduced by multiplex PCR, analysed by Ion reporter and the outcomes will be evaluated with diverse online databases and clinical correlations.
Measured: 6 Months
Gene polymorphism
Genes will evaluated by LightSNiPs
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
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, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026828
- Sponsor's protocol ID
- KOU 2019/067
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
- ClinicalTrials.gov ID
- NCT04026828
- Acronym / sponsor ID
- KOU 2019/067
- Keywords
- chronic periodontitis, aggressive periodontitis, expression, polymorphism, mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 19 Jul 2019 (actual)
- 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.
Generalized aggressive Periodontitis (GAgP) and chronic periodontitis (CP) are inflammatory diseases. Little is known about molecular changes and signaling cascade of host response. Inflammatory diseases are undercontrol of genetic and enviromental factors. Transcription factors are gene-specific factors that are often considered to act as a link connecting genetic and enviromental factors.
The aim of this study is to investigate the gene regions that are thought to play a role in the pathogenesis of GAgP and CP, and to interpret new and reliable pathognomonic-prognostic markers in the diagnosis and treatment of these diseases with the help of expression and mutation analyzes and polymorphism studies.
Detailed description
Generalized aggressive Periodontitis (GAgP) is a multifactorial, destructive, inflammatory and complex disease. The progression of the disease is undercontrol of immunologic, microbiologic, environmental and genetic factors. The immunologic and genetic factors are not clearly defined yet.
Chronic periodontitis (CP) is an infectious disease resulting within the supporting tissues of the teeth. It is commonly detected in adults. CP is initiated and sustained by bacterial plaque.
Both AgP and CP are inflammatory diseases. Little is known about molecular changes and signaling cascade of host response. Inflammatory diseases are undercontrol of genetic and environmental factors. Transcription factors are gene-specific factors that are often considered to act as a link connecting genetic and environmental factors.
This research is a continuation project. In the previous 2 studies which were conducted and published with the support of TÜBİTAK 1001 and KOU BAP, it was found 2 gene regions thought to have an effect on GAgP and KP pathogenesis by genomics, proteomics and immunohistochemical methods; MZB1 and ECH1. The aim of this study is to confirm these gene regions by gene expression analysis, mutation analysis and polymorphism studies.
In the literature, there was no study on the genome analysis, protein activity and immunohistochemical examination of these genes in the CP and GAgP. There was no study that evaluated the expression, mutation and polymorphism studies.
The first 2 steps of the study were completed with the support provided by Kocaeli University Scientific Research Project Unit [119.500,00 TL (KOU BAP 2013/5)] and TUBITAK [(TÜBİTAK 1001 214S008, 261.500,00 TL)].
The aim of this study is to investigate the gene regions that are thought to play a role in the pathogenesis of GAgP and CP, and to interpret new and reliable pathognomonic-prognostic markers in the diagnosis and treatment of these diseases with the help of expression and mutation analyzes and polymorphism studies. Gene sites identified and clinically relevant in this study will serve as the basis for another study in which these genes are aimed at silencing.,,,
This research is a continuation project. In the previous 2 studies which were conducted and published with the support of TÜBİTAK 1001 and KOU BAP, it was found 2 gene regions that concluded which may have an effect on GAgP and KP pathogenesis by genomics, proteomics and immunohistochemical methods; MZB1 and ECH1. The aim of this study is to confirm these gene regions by gene expression analysis, mutation analysis and polymorphism studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | – | Genetic: Periodontitis GroupChronic periodontitis and aggressive periodontitis patients |
| Control Group | – | Genetic: Periodontitis GroupBoth periodontal and medically healthy volunteers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Having aggressive or chronic periodontitis and healthy volenteers
Key inclusion criteria (8 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),
- Between 18 and 35 years of age,
- Otherwise healthy,
- The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.
- Had at least 20 teeth,
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Periodontitis GroupPeriodontitis group consists of both chronic and aggressive periodontitis patients | Genetic | Control Group, Periodontitis Group |
Primary outcome
Quality and accuracy of the products of RNA and DNA
Time frame: 6 months
RNA and DNA will be isolated from cells and the quality and accuracy of the products will be tested by Agilent 2100 bioanalyzer chips and quatity of the products will be controlled by Nanodrop ND 1000 spectrophotometer.
Mutations Analysis
Time frame: 6 Months
Evaluation will be performed with DNA which extracted from tissues. Amplicons will be reproduced by multiplex PCR, analysed by Ion reporter and the outcomes will be evaluated with diverse online databases and clinical correlations.
Gene polymorphism
Time frame: 6 Months
Genes will evaluated by LightSNiPs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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
Kocaeli University
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Aggressive Periodontitis and 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD (00905422554664, esragd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality and accuracy of the products of RNA and DNA (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2019.