ASSOCİATİON BETWEEN SMOKİNG AND GİNGİVAL CREVİCULAR FLUİD MFN1 AND NLRP3 LEVELS İN INDİVİDUALS WİTH PERİODONTAL HEALTH OR PERİODONTİTİS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Total Amount of MFN1 in Gingival Crevicular Fluid
研究概览
简要总结
This observational study aims to examine the relationship between cigarette smoking and the levels of two proteins, mitofusin-1 (MFN1) and NLRP3, in the fluid found between the teeth and gums. These proteins are involved in processes related to cell function and inflammation.
Adults aged 25-65 years will be included in four groups: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis. Periodontitis is a gum disease that damages the tissues and bone supporting the teeth.
Participants will provide information about their health and smoking history and undergo a periodontal examination. Small samples of fluid from around the gums will be collected using paper strips before periodontal treatment. The samples will be analyzed for MFN1 and NLRP3.
Researchers will compare the amounts of these proteins across the four groups and examine their relationships with periodontal measurements and smoking history. No experimental medication or treatment will be assigned. Participants with periodontitis will be offered routine periodontal care after sample collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Aged 18-65 years. At least 20 natural teeth. For the periodontal health groups: periodontal health on an intact periodontium, with probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis.
- •For the periodontitis groups: Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification.
- •For the smoking groups: current cigarette smoking of at least 10 cigarettes per day for at least 5 years.
- •For the nonsmoking groups: fewer than 100 cigarettes smoked during the lifetime and no current use of tobacco or nicotine products.
- •Provision of written informed consent.
排除标准
- •ormer cigarette smoking. Use of electronic cigarettes, heated tobacco products, nicotine pouches, or nicotine replacement products.
- •Uncontrolled diabetes, immunodeficiency, autoimmune or chronic inflammatory disease, or a serious systemic disease that may affect periodontal or mitochondrial responses.
- •Pregnancy or breastfeeding. Use of antibiotics, systemic corticosteroids, immunosuppressive medications, or regular anti-inflammatory medications within the previous 3 months.
- •Periodontal treatment within the previous 6 months. Acute oral infection, periodontal abscess, or local pathology affecting the sampling sites.
- •Gingival crevicular fluid samples contaminated with blood or saliva, or insufficient for ELISA analysis.
研究组 & 干预措施
Periodontally Healthy Nonsmokers
Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3.
Periodontally Healthy Smokers
Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3.
Nonsmokers With Periodontitis
Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection.
Smokers With Periodontitis
Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will be current smokers who have regularly smoked at least 10 cigarettes per day for at least 5 years. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection.
结局指标
主要结局
Total Amount of MFN1 in Gingival Crevicular Fluid
时间窗: Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.
The total amount of mitofusin-1 (MFN1) in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). MFN1 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.
次要结局
- Total Amount of NLRP3 in Gingival Crevicular Fluid(The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodonti)
- Full-Mouth Mean Probing Depth(Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.)
- Full-Mouth Mean Clinical Attachment Level(Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.)
- Percentage of Sites With Bleeding on Probing(Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.)
- Full-Mouth Mean Plaque Index(Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.)
- Full-Mouth Mean Gingival Index(Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.)
研究者
Zeynep AKGÜL
Assist Prof
Abant Izzet Baysal University