Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Salivary Mitofusin-1 (Mfn1) Concentration at Baseline
研究概览
简要总结
Periodontitis (gum inflammation) is a common disease worldwide. This study aims to investigate a novel biomarker, a protein called Mitofusin-1 (Mfn1), in saliva that may be associated with the severity of periodontitis and response to treatment. The study will include periodontally healthy individuals, individuals with mild to severe periodontitis, and smokers with severe periodontitis. Participants will receive saliva samples and undergo clinical periodontal examinations. Individuals with periodontitis will receive standard periodontal treatment, and changes in Mfn1 levels will be assessed 3 months after treatment. The study is expected to shed light on the potential utility of Mfn1 as a marker in the diagnosis and follow-up of periodontitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Willing and able to provide written informed consent.
- •Systemically healthy (no history of diabetes mellitus, immunodeficiency, malignancy, or other systemic conditions that could affect periodontal status).
- •Have a minimum of 20 natural teeth (excluding third molars).
- •No antibiotic therapy or periodontal treatment in the last 6 months.
- •For Healthy Control Group:
- •No clinical attachment loss. Probing depth ≤ 3 mm. No radiographic evidence of bone loss. Low gingival and plaque index scores.
- •For Mild Periodontitis Group:
- •Diagnosed with Stage I or II periodontitis according to the 2018 AAP/EFP classification.
- •Clinical attachment loss of 1-4 mm. Radiographic bone loss of ≤15-33%. Non-smoker.
- •For Severe Periodontitis Group:
- •Diagnosed with Stage III or IV periodontitis according to the 2018 AAP/EFP classification.
- •Clinical attachment loss ≥ 5 mm. Radiographic bone loss to the mid-advanced level of the root. Non-smoker.
- •For Severe Periodontitis with Smoking Group:
- •Meets all criteria for the Severe Periodontitis Group. Regular smoker (at least 10 cigarettes per day for a minimum of 5 years).
排除标准
- •Fewer than 20 natural teeth (excluding third molars).
- •Presence of any systemic disease (e.g., diabetes mellitus, immunological disorders, cancer).
- •Use of antibiotics or receiving periodontal treatment in the last 6 months.
- •Pregnancy or lactation.
- •For non-periodontitis groups (Healthy Control): Any signs of periodontitis.
- •For periodontitis groups (all): History of smoking cessation for at least 5 years (must be either a current regular smoker or a never-smoker, depending on the group definition).
结局指标
主要结局
Salivary Mitofusin-1 (Mfn1) Concentration at Baseline
时间窗: Baseline
Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group.
次要结局
- Salivary Glutathione Peroxidase (GPx) Concentration(Baseline)
- Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration(Baseline)
- Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)(Baseline)
- Change in Salivary Mfn1 Concentration After Periodontal Therapy(Baseline and 3 months)
- Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL)(Baseline)
- Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI)(Baseline)
- Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI)(Baseline)
研究者
Ömer Faruk Okumuş
assistant professor
Erzincan University