Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Sponsors
Source
Kocaeli University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief 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. 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.
Overall Status
Not yet recruiting
Start Date
2019-09-01
Completion Date
2022-07-15
Primary Completion Date
2021-08-31
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Quality and accuracy of the products of RNA and DNA |
6 months |
|
Mutations Analysis |
6 Months |
|
Gene polymorphism |
6 Months |
Number Of Groups
2
Enrollment
200
Conditions
Intervention
Intervention Type
Genetic
Intervention Name
Description
Periodontitis group consists of both chronic and aggressive periodontitis patients
Arm Group Label
Periodontitis Group
Control Group
Eligibility
Study Pop
Having aggressive or chronic periodontitis and healthy volenteers
Sampling Method
Non-Probability Sample
Criteria
Inclusion criteria for 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),
- 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.
Inclusion criteri for chronic periodontitis 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.
Inclusion criteri for control individuals;
- Overall healthy individuals (dental, periodontal and systemically)
Exclusion Criteria for all individuals;
- 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
Gender
All
Minimum Age
N/A
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD |
Principal Investigator |
Kocaeli University |
Overall Contact
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Kocaeli University
Investigator Full Name
Esra Guzeldemir-Akcakanat
Investigator Title
Chair of the Department of Periodontology
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Periodontitis Group
Description
Chronic periodontitis and aggressive periodontitis patients
Arm Group Label
Control Group
Description
Both periodontal and medically healthy volunteers.
Firstreceived Results Date
N/A
Biospec Retention
Samples With DNA
Biospec Descr
Gingival tissues
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Control
Time Perspective
Prospective
Study First Submitted
July 12, 2019
Study First Submitted Qc
July 17, 2019
Study First Posted
July 19, 2019
Last Update Submitted
July 24, 2019
Last Update Submitted Qc
July 24, 2019
Last Update Posted
July 25, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.