Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465095
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Evaluation of Inflammasome Gene Polymorphisms in Periodontitis Patients
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Evaluation of Inflammasome Gene Polymorphisms in Patients With Stage III Grade B and C Periodontitis
Status:
RECRUITING
Status Verified Date:
2024-02
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 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
Detailed 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 005 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 025-1 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 -80C 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
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 005 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 025-1 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 -80C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None