Chronic PeriodontitisNCT06400069
Role of NLRP6 in Chronic Periodontitis
An observational study of Chronic Periodontitis, run by Babol University of Medical Sciences at 1 site in Iran.
Trial summary
The quantification of NLRP6 in blood samples will be analyzed from individuals with chronic periodontitis but without systemic disease. Demographic and periodontal parameters will be assessed and correlated with the NLRP6 quantification using RT-PCR. Read more about this study
- Who is it for?
- Ages 25 to 79 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Evaluation of serum NLRP6 levels
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 13 Dec 2024to 22 Nov 2025
- 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 25 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the periodontology department of the University School of Dentistry Medical sciences of Babol
Who may be able to join
- Age: At least 25 years old
- Clinical diagnosis of chronic periodontitis
- At least 15 teeth in the mouth
Who cannot join
- premalignant lesions and cancer of the oral cavity
- periodontal treatment in the last 6 months
- systemic disorders affecting the periodontal condition (autoimmunity and endocrine disorders)
- diabetes mellitus and rheumatoid arthritis
- pregnancy or breastfeeding
- taking drugs with the possibility of affecting the periodontal condition (calcium channel blockers, anticonvulsants, etc.)
- Smoking
- aggressive PD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum NLRP6 in Chronic Periodontitis Patients
The quantification of NLRP6 in blood samples will be analyzed from individuals with chronic periodontitis but without systemic disease. Demographic and periodontal parameters will be assessed and correlated with the NLRP6 quantification using RT-PCR.
Read the detailed description
This study aims to collect demographic variables, including age, education level, BMI, personal habits, medication use, and history of systemic disease, from non-smoking individuals with chronic periodontitis. Initially, we will determine the expression level of the NLRP6 gene in blood samples taken from chronic periodontitis subjects who are matched for age and sex. Subsequently, we will investigate the relationship between gene expression levels, taking into account the confounding effect of body mass index, and explore how these levels correlate with the severity of the disease.
In this study, two groups: chronic periodontitis (CP) and healthy controls (HC) will be examined. The CP group will consist of patients diagnosed with Stage I to IV periodontitis based on the consensus report from the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Additionally, we will include systemically healthy individuals. Serum samples will be collected from all patients, and the Plaque Index (PI) and Gingival Index (GI) will be recorded at four sites per tooth. Furthermore, we will assess full-mouth probing depth (PD) and clinical attachment level (CAL) at six sites per tooth. The percentage of bleeding areas will be documented as the proportion of sites with bleeding on probing (BOP) within 20 seconds after probing.
For blood sampling, a total of 3 mL of blood will be collected from the antecubital vein of each individual by an expert nurse from the Department of Periodontology.
Statistical analysis will be conducted using statistical software for data science (Stata version 17). A significance value (p-value) of less than 0.05 will be considered statistically significant. The sample size for the study was determined using the power paired means module in Stata 17. We planned to include at least 25 individuals in each group, aiming for a significance level of 5%, statistical power of 80%, and a correlation coefficient of 0.2.
- Conditions
- Chronic Periodontitis
- Being tested
- Evaluation of serum NLRP6 levels
- Keywords
- NLRP6 Protein, human, Chronic Periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of serum NLRP6 levelsOther
intervention: Evaluation of serum NLRP6 levels control: Evaluation of serum NLRP6 levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start13 Dec 2024
- Primary completion28 Feb 2025
- Study completion22 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babol University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morteza Rabbani, Babol University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400069
- Sponsor's protocol ID
- IR.MUBABOL.REC.1403.037
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum NLRP6 in Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06400069
- Acronym / sponsor ID
- IR.MUBABOL.REC.1403.037
- Conditions
- Chronic Periodontitis
- Keywords
- NLRP6 Protein, human, Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Babol University of Medical SciencesUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 22 Nov 2025 (actual)
- First posted
- 6 May 2024 (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.
The quantification of NLRP6 in blood samples will be analyzed from individuals with chronic periodontitis but without systemic disease. Demographic and periodontal parameters will be assessed and correlated with the NLRP6 quantification using RT-PCR.
Detailed description
This study aims to collect demographic variables, including age, education level, BMI, personal habits, medication use, and history of systemic disease, from non-smoking individuals with chronic periodontitis. Initially, we will determine the expression level of the NLRP6 gene in blood samples taken from chronic periodontitis subjects who are matched for age and sex. Subsequently, we will investigate the relationship between gene expression levels, taking into account the confounding effect of body mass index, and explore how these levels correlate with the severity of the disease.
In this study, two groups: chronic periodontitis (CP) and healthy controls (HC) will be examined. The CP group will consist of patients diagnosed with Stage I to IV periodontitis based on the consensus report from the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Additionally, we will include systemically healthy individuals. Serum samples will be collected from all patients, and the Plaque Index (PI) and Gingival Index (GI) will be recorded at four sites per tooth. Furthermore, we will assess full-mouth probing depth (PD) and clinical attachment level (CAL) at six sites per tooth. The percentage of bleeding areas will be documented as the proportion of sites with bleeding on probing (BOP) within 20 seconds after probing.
For blood sampling, a total of 3 mL of blood will be collected from the antecubital vein of each individual by an expert nurse from the Department of Periodontology.
Statistical analysis will be conducted using statistical software for data science (Stata version 17). A significance value (p-value) of less than 0.05 will be considered statistically significant. The sample size for the study was determined using the power paired means module in Stata 17. We planned to include at least 25 individuals in each group, aiming for a significance level of 5%, statistical power of 80%, and a correlation coefficient of 0.2.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the periodontology department of the University School of Dentistry Medical sciences of Babol
Key inclusion criteria (3 listed)
- Age: At least 25 years old
- Clinical diagnosis of chronic periodontitis
- At least 15 teeth in the mouth
Key exclusion criteria (8 listed)
- premalignant lesions and cancer of the oral cavity
- periodontal treatment in the last 6 months
- systemic disorders affecting the periodontal condition (autoimmunity and endocrine disorders)
- diabetes mellitus and rheumatoid arthritis
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of serum NLRP6 levelsintervention: Evaluation of serum NLRP6 levels control: Evaluation of serum NLRP6 levels | Other | – |
Primary outcome
Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR
Time frame: 12 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 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Periodontitis, run by Babol University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 8 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 24 Nov 2025. 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 Iran. 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?
Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.