Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06351722 |
Other study ID # |
smokingnlrp3inflasome |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 15, 2024 |
Est. completion date |
March 15, 2025 |
Study information
Verified date |
April 2024 |
Source |
Necmettin Erbakan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this observational is to analyze the relationship between levels of
interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α),
interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding
oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like
protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA
host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral
mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the
changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate
potential confounders that may mediate this relationship.
The main questions it aims to answer are:
question 1: Is there a relationship between the biomarkers mentioned above and periodontitis
and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers
and non-smokers?
Description:
There will be 4 groups in the study: Non-smoking periodontitis (NSP), smoking periodontitis
(SP), non-smoking healthy control (HC), and smoking healthy control (HCS).
The periodontitis groups in the study (NSP and SP) will include patients diagnosed with Stage
II and III, generalized, Grade B, C periodontitis clinically based on the consensus report of
the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and
Conditions, and systemically healthy individuals. Patients with clinical attachment loss ≥3
mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic
bone loss extending to or beyond the middle third of the root in the coronal third will be
included. Patients with periodontal disease-related tooth loss ≤4 teeth will be included.
Disease progression rate will be graded as B or C Class based on direct evidence of disease
progression confirmed by panoramic radiographs and evidence of indirect destruction
proportional to biofilm accumulations. In the smoking periodontitis group (SP) and smoking
healthy group (HCS), participants who reported smoking >10 cigarettes per day for >5 years
will be included, while participants in the non-smoking groups (NSP and HC) will be those who
reported never smoking.
Clinical Measurements and Non-surgical Periodontal Treatment
Saliva and serum samples will be collected from all patients initially and 3 months after
NSPT. Clinical parameters will also be recorded initially and at the 3rd month. Plaque index
(PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing
depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and
the percentage of bleeding areas will be recorded as present or absent within 20 seconds
after probing using a binary scoring system. A calibrated periodontologist (ZTE) will record
all clinical parameters using manual probing. Examiner calibration will be provided before
starting the study on a small pilot population to achieve consistent intra-examiner accuracy.
After the collection of baseline samples and clinical parameter records, all patients will
receive initial periodontal treatment, including patient education, full-mouth scaling, and
root planing (SRP), and oral hygiene instructions from the same experienced clinician (ZTE).
Laboratory Measurement
Each patient will be instructed to abstain from eating, drinking, and oral hygiene practices
for 12 hours before sampling. Serum and saliva samples will be collected from each patient
between 8:00 and 10:00 in the morning before dental examination.
Blood Sampling: In the scope of the study, a total of 5 mL of blood will be collected from
the antecubital vein of each individual by an expert nurse from the Department of
Periodontology.
For serum sampling, venous puncture will be performed, and blood samples will be collected,
immediately cooled on ice, and centrifuged at 4°C (800 rpm for 10 minutes). After the
collection of saliva samples, they will be centrifuged immediately at 4°C (1000 rpm for 2
minutes). Following sampling, both serum and saliva samples will be stored at -80°C until
analysis. Concentrations of NLRP3, ASC, caspase-1, IL-18, IL-1beta, TNF-alfa, IL-10,
TGF-beta, and SIRT-1 will be analyzed by specific enzyme-linked immunosorbent assay (ELISA)
kits in both serum and saliva samples. LncRNA SNHG5 and MEG3 will be examined using Real-time
polymerase chain reaction (RT-PCR).
IL-18, IL-1beta, TNF-alfa, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels in
PMBC will be evaluated using RT-PCR. All analysis steps for each kit will be evaluated using
the protocol recommended by the manufacturer.
Statistical Analysis:
Statistical analysis will be performed using commercially available software (SPSS version
22.0, SPSS). In this study, a significance value (p-value) of <0.05 will be used. This study
is designed as a prospective controlled clinical trial. The sample size of the study was
calculated using the R Statistical Language program (version 4.1.2; The R Foundation for
Statistical Computing, Vienna, Austria; http://www.r-project.org). It was planned to include
at least 25 individuals in each group for One-Way Analysis of Variance analysis to be
conducted with a significance level of 5%, statistical power of 80%, and effect size of 0.4
(Cohen's f=0.4) to determine if there is a significant difference in inflammatory factors
between the study groups (smoking periodontitis, smoking periodontally healthy, non-smoking
periodontitis, non-smoking periodontally healthy).
Longitudinal analyses will include data only from patients who complete the entire study
protocol.