The Effect of Non Surgical Periodontal Therapy on the Ratio of TNF-α to IL-10 in Periodontitis Patients With Diabetics Mellites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes
研究概览
简要总结
Periodontitis is a chronic inflammatory disease affecting the periodontium, characterized by irreversible damage to the gingiva, periodontal ligament, and alveolar bone. It is prevalent among adults, significantly impacting oral health and quality of life. This study investigates the effect of non-surgical periodontal therapy (NSPT) on the levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10) in periodontitis patients with and without diabetes mellitus type II.
详细描述
A single-blinded, randomized clinical trial was conducted on 36 patients with generalized periodontitis, recruited from Ain-Shams University's outpatient clinic. Patients were divided into three groups: poorly controlled diabetes with periodontitis (HbA1c ≥ 7%), controlled diabetes with periodontitis (HbA1c < 7%), and non-diabetic periodontitis. Full-mouth NSPT was performed, and clinical parameters (Plaque Index, Bleeding Index, Pocket Depth, Clinical Attachment Level) were assessed at baseline and eight weeks post-treatment. Venous blood samples were collected to measure TNF-α and IL-10 levels using ELISA kits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders. Age (20-50 ) years old. Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
- •Generalized Periodontitis patients . Having at least 20 tooth excluding wisdoms. Systemically free according to the modified Burkett's health history questionnaire except for diabetes mellitus (Burket, Greenberg and Glick 2003).
排除标准
- •Intake of immunosuppressive drugs, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study .
- •status of pregnancy or lactation.
- •allergy to local anesthetic.
- •Prisoners .
- •The vulnerable group ; mentally and physically disabled patients .
结局指标
主要结局
detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes
时间窗: 8 weeks
To detect difference in the ratio of the proinflammatory cytokine tumor necrosis factor-α to the anti-inflammatory cytokine interleukin-10 between periodontitis patients with and without type 2 diabetes mellitus before and after non surgical periodontal therapy.
次要结局
未报告次要终点