Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-30
Brief Title:
Role of NLRP6 in Chronic Periodontitis
Sponsor:
Babol University of Medical Sciences
Organization:
Babol University of Medical Sciences
Study Overview
Official Title:
Evaluation of Serum NLRP6 in Chronic Periodontitis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 005 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 02
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 005 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 02
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None