Evaluation of Inflammasome Gene Polymorphisms in Periodontitis Patients

NCT06465095 | Recruiting

• 1 other identifier: 09-2023-1700
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Periodontitis

Keywords

Periodontitis, gene, polymorphism

Outcome Measures

Primary Outcomes (1)

• NLRP3 gene polymorphism

  SNP

  Baseline

Secondary Outcomes (2)

• AIM2 gene polymorphism

  Baseline

• IFI16

  Baseline

Study Arms (3)

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

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

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

Interventions

Baseline GENETIC

Measurements and sampling

Healthy; Stage III Grade B Periodontitis; Stage III Grade C Periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-02

Locations

TU (1)