PeriodontitisNCT07590089
Relationship Between NLRP3 Inflammasome Activation and Stages of Periodontitis: An Association With Inflammaging
An observational study of Periodontitis and Periodontitis Stage I, run by Misr University for Science and Technology at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontitis Stage I, Periodontitis Stage II
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 20 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Periodontology, Faculty of Dentistry, [MUST University]
Cairo
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 months
Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RANDA SHEABAN SHINKADA, Misr University for Science and Technology
- Investigators
- RANDA SHAEBAN SHINKADA, MASTER, Principal investigator, RANDA SHAEBAN SHINKADA. MUSTRADWA Mohamed, PHD, Study director, RADWA MOHAMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590089
- Sponsor's protocol ID
- NLRP3-PD-2026
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between NLRP3 Inflammasome Activation and Different Stages of Periodontitis and Its Association With Inflammaging
- ClinicalTrials.gov ID
- NCT07590089
- Acronym / sponsor ID
- NLRP3-PD-2026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publicationMarchesan 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RANDA SHAEBAN SHINKADA, MASTER principal investigator
RANDA SHAEBAN SHINKADA. MUST
RADWA Mohamed, PHD study director
RADWA MOHAMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontitis Stage I, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of NLRP3 Inflammasome in Gingival Crevicular Fluid Among Different Stages of Periodontitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.