Effect of Non-surgical Periodontal Treatment in Smokers on SIRT-1 and Proteins of the NLRP3 Inflammasome and Long Noncoding RNAs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pre-treatment clinical and laboratory evaluation
研究概览
简要总结
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?
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 3rd month after non-surgical periodontal treatment (Diagnostic Test)
non-smoking periodontal health (HC)
participants who reported never smoking and periodontal healthy.
干预措施: Before non-surgical periodontal treatment (Diagnostic Test)
smoking periodontal health (HCS)
participants who reported smoking >10 cigarettes per day and periodontal healthy.
干预措施: Before non-surgical periodontal treatment (Diagnostic Test)
结局指标
主要结局
Pre-treatment clinical and laboratory evaluation
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Zeynep Tastan Eroglu
assistant professor
Necmettin Erbakan University