- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590089
Relationship Between NLRP3 Inflammasome Activation and Stages of Periodontitis: An Association With Inflammaging
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
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Department of Periodontology, Faculty of Dentistry, [MUST University]
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
20 Patients with chronic periodontitis (stage I) and Grade) (A )18 to 40years.
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Group 2
20 Patients with chronic periodontitis (stage II /III) and Grade (B/ C) aged between 18 to 40 years.
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Group 3
20 Patients with chronic periodontitis (stage I) and Grade) (A) aged 50 and above years.
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Group 4
20 Patients with chronic periodontitis (stage II /III) and (Grade B/ C) aged 50 years and above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Concentration of NLRP3 Inflammasome in Gingival Crevicular Fluid Among Different Stages of Periodontitis
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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6 months
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Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: RANDA SHAEBAN SHINKADA, MASTER, RANDA SHAEBAN SHINKADA. MUST
- Study Director: RADWA Mohamed, PHD, RADWA MOHAMED
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLRP3-PD-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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