Clinical trial NCT04026828: Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Official title: Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Generalized Aggressive Periodontitis
Chronic Periodontitis
Keywords: chronic periodontitis
aggressive periodontitis
expression
polymorphism
mutation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Having aggressive or chronic periodontitis and healthy volenteers

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.

Eligibility 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

Primary outcomes:
measure: Quality and accuracy of the products of RNA and DNA
timeFrame: 6 months
measure: Mutations Analysis
timeFrame: 6 Months
measure: Gene polymorphism
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kocaeli University
name: ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: