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

NCT07590089 | Completed DMC

• 1 other identifier: NLRP3-PD-2026
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Periodontitis Stage I; Periodontitis Stage II; Periodontitis Stage III

Outcome Measures

Primary Outcomes (1)

• Concentration of NLRP3 Inflammasome in Gingival Crevicular Fluid Among Different Stages of Periodontitis

  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 Outcomes (2)

• RELATCorrelation Between NLRP3 Inflammasome Concentration and Clinical Periodontal ParametersIONSHIP BETWEEN NLRP3 INFLAMMASOME ACTIVATION AND STAGES OF PERIODONTITIS: AN ASSOCIATION WITH INFLAMMAGING

  6 months

• Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid

  6 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (1)

• 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.

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and/or gingival crevicular fluid (GCF) samples will be collected from participants. These samples will be used to assess levels of NLRP3 inflammasome components. Samples will be stored under appropriate laboratory conditions for analysis.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• RANDA SHAEBAN SHINKADA, MASTER

  RANDA SHAEBAN SHINKADA. MUST

  PRINCIPAL INVESTIGATOR

• RADWA Mohamed, PHD

  RADWA MOHAMED

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 15, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 20, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)