Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods

NCT ID: NCT04026828

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-07-15

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.

Conditions

Generalized Aggressive Periodontitis; Chronic Periodontitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Periodontitis Group

Chronic periodontitis and aggressive periodontitis patients

Periodontitis Group

Intervention Type: GENETIC

Periodontitis group consists of both chronic and aggressive periodontitis patients

Control Group

Both periodontal and medically healthy volunteers.

Periodontitis Group

Intervention Type: GENETIC

Periodontitis group consists of both chronic and aggressive periodontitis patients

Interventions

Periodontitis Group

Periodontitis group consists of both chronic and aggressive periodontitis patients

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Esra Guzeldemir-Akcakanat

Chair of the Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Central Contacts

ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD

Role: CONTACT

esragd@yahoo.com

00905422554664

Other Identifiers

KOU 2019/067

Identifier Type: -

Identifier Source: org_study_id