Evaluation of Inflammasome Gene Polymorphisms in Periodontitis Patients

Evaluation of Inflammasome Gene Polymorphisms in Patients With Stage III, Grade B and C Periodontitis

The present study aimed to evaluate the distribution of NLRP3, AIM2, and IFI16 inflammasome gene polymorphisms in individuals with Stage III Grade B and C periodontitis and periodontally healthy individuals. 80 periodontally healthy, 80 Stage III Grade B and 80 Stage III Grade C periodontitis patients will be enrolled. Blood samples will be collected from each participants and clinical parameteres will be recorded for whole mouth. DNA isolation will be performed from all samples. The SNP regions with the numbers rs4612666, rs75985579, and rs2793845 will be detected from DNA material using Real-Time PCR device genotyping kits. Data will be analyzed using statistical tests.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Periodontal Diseases
• Intervention / Treatment: Genetic: Baseline

Detailed Description

Innate immune response is the first line of defense mechanism of the body against pathogens. One of the most important proteins involved in the innate immune response are the inflammasomes which are multimeric protein complexes composed of a sensor molecule (the PRR), typically the adapter molecule apoptosis-associated speck-like protein containing a caspase-recruitment domain (CARD), and the protease caspase-1. Different types of inflammasomes have been described. In periodontal disease, inflammasome activation is associated with the release of pro-inflammatory cytokines, which can lead to tissue destruction and periodontal damage.

Progression rate, onset age, and severity of periodontal disease are influenced by some modifiable or non-modifiable risk factors present in the host. Genetic polymorphisms are non-modifiable risk factors for periodontitis. Variations in inflammasome genes may be determinants in the development of periodontal disease by leading to diversity in inflammatory markers.

Sample size is determined based on a previous study which analyzes the effect of NLRP3 gene polymorphism on periodontitis susceptibility. For rs4612666 group, with an α value of 0.05 and a power of 80%, it is determined that there should be 80 participants in each group. Totally 240 patients are included (80 periodontally healthy, 80 Stage III Grade B periodontitis, 80 Stage III Grade C periodontitis). The whole mouth clinical periodontal examination includes measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. Periodontal diagnosis of each patient has been made according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Healthy group includes individuals without a clinical inflammation pattern and a history of periodontitis, with no detected clinical attachment and bone loss, BOP < 10%, probing depth ≤ 3 mm. Stage III Grade B periodontitis patients have minimum of 20 teeth (except third molars), with CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically showing bone loss extending up to one-third of the root, percantage of bone lose by age is 0.25-1 and Stage III Grade C patients have minimum of 20 teeth (except third molars), with CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically showing bone loss extending up to one-third of the root, percantage of bone lose by age is >1.

Sample Collection and DNA Isolation and Genotyping A total of 5 mL of blood is collected from the antecubital fossa by venepuncture method from each participants and stored at -80°C until analysis day. DNA isolation has been made using genomic DNA kits. rs4612666, rs75985579, and rs2793845 SNP regions are detected from DNA material using Real-Time PCR device genotyping kits.

Statistical analysis has been performed with standard statistical software package by selecting appropriate tests.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • İstanbul, Maltepe, Turkey, 34854
      • Recruiting
      • Marmara University
      • Contact: Hafize Öztürk Özener; Phone Number: 3765376; Email: hafize.ozturk@marmara.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Sistemically healthy, non-smokers. Periorodontally healthy, stage III perodontitis B and C periodontitis patients.

Description

Inclusion Criteria:

• systematically healthy, non-smoker individuals
• patients between the ages of 18 and 65
• individuals with periodontally healthy, stage III grade B and C periodontitis diagnoses

Exclusion Criteria:

• having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis...
• Usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months.
• Periodontal treatment within the preceding 6 months.
• Pregnant/ lactating/ postmenopausal females.
• Current orthodontic treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Individuals without a clinical inflammation pattern and a history of periodontitis, with no detected clinical attachment and bone loss, BOP < 10%, probing depth ≤ 3 mm.	Genetic: Baseline; Measurements and sampling
Stage III Grade B Periodontitis; Individuals that have minimum of 20 teeth (except third molars), with CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically showing bone loss extending up to one-third of the root, percantage of bone lose by age is 0.25-1 will be included.	Genetic: Baseline; Measurements and sampling
Stage III Grade C Periodontitis; Individuals that have minimum of 20 teeth (except third molars), with CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically showing bone loss extending up to one-third of the root, percantage of bone lose by age is >1 will be included.	Genetic: Baseline; Measurements and sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NLRP3 gene polymorphism	SNP	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AIM2 gene polymorphism	SNP	Baseline
IFI16	SNP	Baseline

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): April 14, 2025
• Study Completion (Estimated): April 14, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis, gene, polymorphism
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: 09-2023-1700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No