Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods

July 24, 2019 updated by: Esra Guzeldemir-Akcakanat, Kocaeli University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD
  • Phone Number: 00905422554664
  • Email: esragd@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Having aggressive or chronic periodontitis and healthy volenteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Periodontitis Group
Chronic periodontitis and aggressive periodontitis patients
Genetic: Periodontitis Group
Periodontitis group consists of both chronic and aggressive periodontitis patients
Control Group
Both periodontal and medically healthy volunteers.
Genetic: Periodontitis Group
Periodontitis group consists of both chronic and aggressive periodontitis patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 Months
Gene polymorphism
Time Frame: 6 Months
Genes will evaluated by LightSNiPs
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KOU 2019/067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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