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NCT Number: NCT07590089

Relationship Between NLRP3 Inflammasome Activation and Stages of Periodontitis: An 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Periodontology, Faculty of Dentistry, [MUST University]

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Misr University for Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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