Effect of Non-surgical Periodontal Treatment in Smokers on SIRT-1 and Proteins of the NLRP3 Inflammasome and Long Noncoding RNAs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pre-treatment clinical and laboratory evaluation
Study Overview
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 (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?
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Being between the ages of 18 and 65
- •Being diagnosed as "periodontally healthy" or "periodontitis" based on periodontal examination
- •Not having any accompanying systemic diseases (such as diabetes, cardiovascular diseases, etc.)
- •Agreeing to participate in the study
Exclusion Criteria
- •Use of contraceptive medications
- •Use of anti-inflammatory, antibiotic, immunosuppressive, or other medications - that could affect the study outcomes within the previous 6 months
- •History of excessive alcohol consumption
- •Pregnancy or breastfeeding
- •Undergoing periodontal treatment within the previous 6 months
- •Refusal to participate in the study
Arms & Interventions
Non-smoking periodontitis (NSP)
participants who reported never smoking, 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.
Intervention: Before non-surgical periodontal treatment (Diagnostic Test)
Non-smoking periodontitis (NSP)
participants who reported never smoking, 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.
Intervention: non-surgical periodontal treatment (Procedure)
Non-smoking periodontitis (NSP)
participants who reported never smoking, 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.
Intervention: 3rd month after non-surgical periodontal treatment (Diagnostic Test)
smoking periodontitis (SP)
participants who reported smoking >10 cigarettes per day for >5 years 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.
Intervention: Before non-surgical periodontal treatment (Diagnostic Test)
smoking periodontitis (SP)
participants who reported smoking >10 cigarettes per day for >5 years 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.
Intervention: non-surgical periodontal treatment (Procedure)
smoking periodontitis (SP)
participants who reported smoking >10 cigarettes per day for >5 years 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.
Intervention: 3rd month after non-surgical periodontal treatment (Diagnostic Test)
non-smoking periodontal health (HC)
participants who reported never smoking and periodontal healthy.
Intervention: Before non-surgical periodontal treatment (Diagnostic Test)
smoking periodontal health (HCS)
participants who reported smoking >10 cigarettes per day and periodontal healthy.
Intervention: Before non-surgical periodontal treatment (Diagnostic Test)
Outcomes
Primary Outcomes
Pre-treatment clinical and laboratory evaluation
Time Frame: baseline
Comparison of clinical measurements and IL-18, IL-1beta, TNF-alpha, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels of the 4 groups in the study
Comparison of clinical measurements and laboratory measurements at 3 months post-treatment
Time Frame: 3rd month after NSPT
Comparison of clinical measurements and IL-18, IL-1beta, TNF-alpha, IL-10, TGF-beta, NLRP3, SIRT-1, lncRNA SNHG5, and MEG3 levels of periodontitis groups (NSP and SP) at the 3rd month after treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Zeynep Tastan Eroglu
assistant professor
Necmettin Erbakan University