Role of NLRP6 in Chronic Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: Evaluation of serum NLRP6 levels

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Iran
  • Babol, Iran
    • Dental School, Periodontology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the periodontology department of the University School of Dentistry Medical sciences of Babol

Description

Inclusion Criteria:

• Age: At least 25 years old
• Clinical diagnosis of chronic periodontitis
• At least 15 teeth in the mouth

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR	12 months

Collaborators and Investigators

• Sponsor: Babol University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): November 22, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Periodontitis; NLRP6 Protein, human
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Pathological Conditions, Signs and Symptoms; Chronic Periodontitis
• Other Study ID Numbers: IR.MUBABOL.REC.1403.037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No