Efficacy of scaling and root planing on salivary leptin and interleukin 6 levels in patients with metabolic syndrome and periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Will the salivary leptin and interleukin-6 (IL-6) levels will be decreased three months after scaling and root planning?
研究概览
简要总结
Aim and ObjectivesThe principal aim is to assess whether scaling and root planing can beneficially impact salivary leptin and IL-6 levels in affected patients. Objectives include evaluating improvements in biochemical markers and clinical periodontal parameters (plaque index, probing pocket depth, clinical attachment loss).
MethodsA parallel arm interventional study will be conducted on 40 patients aged 35–60 years, divided into two groups: one with periodontitis only, and one with both periodontitis and metabolic syndrome. Salivary samples will be collected using the passive drool method and analyzed for leptin and IL-6 levels by ELISA at baseline and three months post-intervention.
Expected OutcomesThe study expects decreased salivary leptin and IL-6 levels three months after scaling and root planing, along with improvements in periodontal health measures. These outcomes will clarify the systemic benefits of periodontal therapy and support integrated care for patients with chronic inflammatory conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- ••Patients aged between 35-60 years.
- ••Patients with chronic periodontitis only (bleeding on probing present).
- ••Probing pocket depth more than 5 mm.
- ••Clinical attachment loss more than 3 mm.
- ••Periodontitis patients with metabolic syndrome as per the criteria of the International Diabetes Federation (IDF).
- •IDF criteria for metabolic syndrome: The International Diabetes Federation (IDF) defines metabolic syndrome as the presence of central obesity and at least two of the following four factors:
- •Triglycerides: Raised levels of triglycerides, defined as at least 150 mg/dL
- •HDL cholesterol: Reduced levels of HDL cholesterol, defined as less than 40 mg dL for men and less than 50 mg dL for women
- •Blood pressure: Raised blood pressure, defined as at least 130/85 mm Hg
- •Fasting plasma glucose: Raised levels of fasting plasma glucose, defined as at least 100 mg/dL.
排除标准
- ••Pregnancy or lactation.
- ••Use of antibiotics or anti-inflammatory drugs in the last 3 months.
- ••Smokers or alcohol consumers with known addiction.
- ••Any systemic inflammatory or autoimmune diseases.
结局指标
主要结局
Will the salivary leptin and interleukin-6 (IL-6) levels will be decreased three months after scaling and root planning?
时间窗: Baseline and 3 months
次要结局
- Clinical parameters- Plaque index, Probing pocket depth and Clinical attachment levels will be assessed using Williams Probe at baseline and three months after scaling and root planing.(baseline and 3 months)
研究者
Sohail Ahmed
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre