Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Probing depth change
研究概览
简要总结
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.
详细描述
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
- •be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
- •present at least 20 teeth;
- •agree to participate in the study and sign the informed consent form
排除标准
- •patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
- •have undergone periodontal treatment in the last 12 months;
- •have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
- •make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
- •have changed the medication for glycemic control in the last 3 months;
- •present dental elements with pulpal or periapical inflammation.
结局指标
主要结局
Probing depth change
时间窗: baseline, 90 and 180 days
The change in the probing depth will be measure in millimeters before and after the treatment.
次要结局
- oxLDL concentration Change(baseline and 180 days)
- LDL, HDL, Total cholesterol, Triacylglycerol(baseline and 180 days)
- Gingival Recession(baseline, 90 and 180 days)
- Clinical Attachment Level(baseline, 90 and 180 days)
- Plaque index(baseline, 90 and 180 days)
- Gingival index(baseline, 90 and 180 days)
研究者
Maria Aparecida Neves Jardini
Professor
Universidade Estadual Paulista Júlio de Mesquita Filho