Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351722
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Non-surgical Periodontal Treatment in Smokers on SIRT-1 NLRP3 Inflammasome and LncRNAs
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
Effect of Non-surgical Periodontal Treatment in Smokers on SIRT-1 and Proteins of the NLRP3 Inflammasome and Long Noncoding RNAs
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 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 PMBCin 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 2How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers
The main questions it aims to answer are
question 1 Is there a relationship between the biomarkers mentioned above and periodontitis and smoking question 2How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers
Detailed 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 800 and 1000 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 4C 800 rpm for 10 minutes After the collection of saliva samples they will be centrifuged immediately at 4C 1000 rpm for 2 minutes Following sampling both serum and saliva samples will be stored at -80C 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 220 SPSS In this study a significance value p-value of 005 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 412 The R Foundation for Statistical Computing Vienna Austria httpwwwr-projectorg 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 04 Cohens f04 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
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 800 and 1000 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 4C 800 rpm for 10 minutes After the collection of saliva samples they will be centrifuged immediately at 4C 1000 rpm for 2 minutes Following sampling both serum and saliva samples will be stored at -80C 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 220 SPSS In this study a significance value p-value of 005 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 412 The R Foundation for Statistical Computing Vienna Austria httpwwwr-projectorg 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 04 Cohens f04 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
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?:
None
Is an FDA AA801 Violation?:
None