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OpenTrials
Completed

NCT Number: NCT06400069

Role of NLRP6 in Chronic Periodontitis

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.

Completed

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Key information

Age range

25 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental School, Periodontology Department

Babol, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of serum NLRP6 levels

Other

intervention: Evaluation of serum NLRP6 levels control: Evaluation of serum NLRP6 levels

Primary outcomes

  1. Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Babol University of Medical Sciences

Other

Registry information

Official study title

Evaluation of Serum NLRP6 in Chronic Periodontitis Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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