Relationship Between NLRP3 Inflammasome Activation and Stages of Periodontitis: An Association With Inflammaging

May 10, 2026 updated by: RANDA SHEABAN SHINKADA, Misr University for Science and Technology

Relationship Between NLRP3 Inflammasome Activation and Different Stages of Periodontitis and Its Association With Inflammaging

This study aims to investigate the relationship between NLRP3 inflammasome activation and different stages of periodontitis, with a focus on its association with inflammaging. Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth, and aging-related inflammation may influence its progression.

The study will include participants with different stages of periodontitis as well as healthy individuals. Clinical periodontal parameters will be recorded, and biological samples such as saliva or gingival crevicular fluid will be collected to measure levels of NLRP3 inflammasome components and inflammatory markers.

The results of this study may help improve understanding of the role of inflammation and aging in periodontal disease and could contribute to better diagnosis and treatment strategies.

Study Overview

Detailed Description

Periodontitis is a chronic inflammatory disease characterized by progressive destruction of the supporting structures of the teeth. Recent evidence suggests that the NLRP3 inflammasome plays a significant role in the pathogenesis of periodontal disease by regulating the production of pro-inflammatory cytokines such as interleukin-1β.

In addition, inflammaging, defined as low-grade chronic inflammation associated with aging, may contribute to increased susceptibility and severity of periodontal disease. However, the relationship between NLRP3 inflammasome activation and different stages of periodontitis, particularly in the context of inflammaging, is not fully understood.

This observational study aims to evaluate the expression levels of NLRP3 inflammasome components in subjects with varying stages of periodontitis compared to healthy controls. Clinical periodontal parameters, including probing depth, clinical attachment level, and bleeding on probing, will be recorded. Biological samples such as saliva and/or gingival crevicular fluid will be collected for laboratory analysis.

The primary objective is to assess the association between NLRP3 activation and disease severity. Secondary objectives include evaluating the correlation between inflammasome markers and aging-related inflammatory changes.

The findings of this study may provide insight into the molecular mechanisms underlying periodontitis progression and highlight potential biomarkers for early diagnosis and therapeutic targets.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

      • Cairo, Egypt
        • Department of Periodontology, Faculty of Dentistry, [MUST University]

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

he study population will include adult participants aged 18 years and above attending the dental clinic. Participants will be categorized into healthy controls and patients with different stages of periodontitis based on clinical periodontal examination. Individuals will be systemically healthy and not under medications affecting periodontal status. Both males and females will be included. Clinical parameters such as probing depth, clinical attachment level, and bleeding on probing will be recorded, and biological samples (saliva and/or gingival crevicular fluid) will be collected for analysis of NLRP3 inflammasome-related biomarkers.

Description

Inclusion Criteria:

  • 1. Male and Female 2. Aged from18 years and above 50. 3. Have at least 15 natural teeth excluding wisdoms. 4. Provide informed consent and willingness to cooperate with study protocol. 5. Stage I periodontitis and Grade A

    • CAL of 1-2 mm
    • Probing depths typically ≤ 3 6. Periodontitis stage II or stage III and Grads B or C patients:
    • CAL from 3-4 mm.
    • Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

  • 1- History of antibiotic in previous three months. 2- Pregnant or lactating female. 3- Treatment with any systemic drug. 4- History of systemic disease. 5- Patients who received periodontal treatment in last 6 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 1
20 Patients with chronic periodontitis (stage I) and Grade) (A )18 to 40years.
Group 2
20 Patients with chronic periodontitis (stage II /III) and Grade (B/ C) aged between 18 to 40 years.
Group 3
20 Patients with chronic periodontitis (stage I) and Grade) (A) aged 50 and above years.
Group 4
20 Patients with chronic periodontitis (stage II /III) and (Grade B/ C) aged 50 years and above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of NLRP3 Inflammasome in Gingival Crevicular Fluid Among Different Stages of Periodontitis
Time Frame: 6 months
NLRP3 inflammasome concentration will be measured in gingival crevicular fluid (GCF) samples collected from participants with different stages of periodontitis using enzyme-linked immunosorbent assay (ELISA). Results will be reported in pg/mL.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RELATCorrelation Between NLRP3 Inflammasome Concentration and Clinical Periodontal ParametersIONSHIP BETWEEN NLRP3 INFLAMMASOME ACTIVATION AND STAGES OF PERIODONTITIS: AN ASSOCIATION WITH INFLAMMAGING
Time Frame: 6 months
The correlation between GCF NLRP3 inflammasome concentration measured by ELISA (pg/mL) and clinical periodontal parameters including probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI) will be assessed.
6 months
Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid
Time Frame: 6 months
The correlation between participant age (years) and GCF NLRP3 inflammasome concentration measured by ELISA (pg/mL) will be evaluated to assess the association with inflammaging.
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: RANDA SHAEBAN SHINKADA, MASTER, RANDA SHAEBAN SHINKADA. MUST
  • Study Director: RADWA Mohamed, PHD, RADWA MOHAMED

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Marchesan JT, et al. NLRP3 inflammasome in periodontitis: pathogenesis and therapeutic implications. Journal of Periodontal Research. 2020. Mitra R, et al. Salivary NLRP3 inflammasome levels in chronic periodontitis. Journal of Clinical Periodontology. 2022.

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 (Actual)

January 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 20, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 10, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NLRP3-PD-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical considerations and to protect participant confidentiality, as this is an academic observational study without a formal data-sharing framework.

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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