NCT04026828

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 12, 2019

Last Update Submit

July 24, 2019

Conditions

Keywords

chronic periodontitisaggressive periodontitisexpressionpolymorphismmutation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    6 Months

  • Gene polymorphism

    Genes will evaluated by LightSNiPs

    6 Months

Study Arms (2)

Periodontitis Group

Chronic periodontitis and aggressive periodontitis patients

Genetic: Periodontitis Group

Control Group

Both periodontal and medically healthy volunteers.

Genetic: Periodontitis Group

Interventions

Periodontitis group consists of both chronic and aggressive periodontitis patients

Control GroupPeriodontitis Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Having aggressive or chronic periodontitis and healthy volenteers

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Gingival tissues

MeSH Terms

Conditions

Chronic PeriodontitisAggressive Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ESRA GUZELDEMIR-AKCAKANAT, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Periodontology

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 19, 2019

Study Start

September 1, 2019

Primary Completion

August 31, 2021

Study Completion

July 15, 2022

Last Updated

July 25, 2019

Record last verified: 2019-07