Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06465095 |
| Other study ID # |
09-2023-1700 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
April 14, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The present study aimed to evaluate the distribution of NLRP3, AIM2, and IFI16 inflammasome
gene polymorphisms in individuals with Stage III Grade B and C periodontitis and
periodontally healthy individuals. 80 periodontally healthy, 80 Stage III Grade B and 80
Stage III Grade C periodontitis patients will be enrolled. Blood samples will be collected
from each participants and clinical parameteres will be recorded for whole mouth. DNA
isolation will be performed from all samples. The SNP regions with the numbers rs4612666,
rs75985579, and rs2793845 will be detected from DNA material using Real-Time PCR device
genotyping kits. Data will be analyzed using statistical tests.
Description:
Innate immune response is the first line of defense mechanism of the body against pathogens.
One of the most important proteins involved in the innate immune response are the
inflammasomes which are multimeric protein complexes composed of a sensor molecule (the PRR),
typically the adapter molecule apoptosis-associated speck-like protein containing a
caspase-recruitment domain (CARD), and the protease caspase-1. Different types of
inflammasomes have been described. In periodontal disease, inflammasome activation is
associated with the release of pro-inflammatory cytokines, which can lead to tissue
destruction and periodontal damage.
Progression rate, onset age, and severity of periodontal disease are influenced by some
modifiable or non-modifiable risk factors present in the host. Genetic polymorphisms are
non-modifiable risk factors for periodontitis. Variations in inflammasome genes may be
determinants in the development of periodontal disease by leading to diversity in
inflammatory markers.
Sample size is determined based on a previous study which analyzes the effect of NLRP3 gene
polymorphism on periodontitis susceptibility. For rs4612666 group, with an α value of 0.05
and a power of 80%, it is determined that there should be 80 participants in each group.
Totally 240 patients are included (80 periodontally healthy, 80 Stage III Grade B
periodontitis, 80 Stage III Grade C periodontitis). The whole mouth clinical periodontal
examination includes measurement of probing depth (PPD), clinical attachment level (CAL),
presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites
per tooth, except the third molars. Periodontal diagnosis of each patient has been made
according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant
Diseases and Conditions. Healthy group includes individuals without a clinical inflammation
pattern and a history of periodontitis, with no detected clinical attachment and bone loss,
BOP < 10%, probing depth ≤ 3 mm. Stage III Grade B periodontitis patients have minimum of 20
teeth (except third molars), with CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically
showing bone loss extending up to one-third of the root, percantage of bone lose by age is
0.25-1 and Stage III Grade C patients have minimum of 20 teeth (except third molars), with
CAL ≥ 5 mm, probing depth ≥ 6mm, and radiographically showing bone loss extending up to
one-third of the root, percantage of bone lose by age is >1.
Sample Collection and DNA Isolation and Genotyping A total of 5 mL of blood is collected from
the antecubital fossa by venepuncture method from each participants and stored at -80°C until
analysis day. DNA isolation has been made using genomic DNA kits. rs4612666, rs75985579, and
rs2793845 SNP regions are detected from DNA material using Real-Time PCR device genotyping
kits.
Statistical analysis has been performed with standard statistical software package by
selecting appropriate tests.
