NCT02589314终止不适用
Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
University of Brasilia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evidence of alteration in periodontal pathogens by PCR
研究概览
简要总结
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontitis group:
- •Minimum of 15 teeh;
- •At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;
- •Control group:
- •Systemically healthy;
- •20 teeth;
- •Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.
排除标准
- •Periodontal treatment in the last six months;
- •Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
- •Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity [BMI 40 kg / m2] or underweight [evil nourished BMI <18.5 kg / m2], etc.); Pregnant or lactating; smoking; Age <30 years; Indigenous groups.
结局指标
主要结局
Evidence of alteration in periodontal pathogens by PCR
时间窗: One year
Evaluate wich periodontal pathogens are detected before and after treatment
Evidence of alteration of immunocellular response by flowcytometry
时间窗: one year
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
时间窗: One year
Dosage of cytokines before and after periodontal treatment
次要结局
未报告次要终点
研究者
Priscilla Farias Naiff
PhD student
University of Brasilia
研究点 (1)
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