Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-02 @ 12:30 AM
Study NCT ID:
NCT06400069
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of NLRP6 in Chronic Periodontitis
Sponsor:
Babol University of Medical Sciences
Organization:
Study Overview
Official Title:
Evaluation of Serum NLRP6 in Chronic Periodontitis Patients
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: