Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06400069 |
| Other study ID # |
724135819 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2024 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Babol University of Medical Sciences |
| Contact |
Morteza Rabbani, Dental student |
| Phone |
905-858-0502 |
| Email |
m.rabbani[@]mubabol.ac.ir |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
