Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in beta defensins 1, 2 and 3
研究概览
简要总结
Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
- •Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
- •Compensated diabetic individuals: compensated type 2 diabetes mellitus
- •Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)
排除标准
- •Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
- •Gingivitis
- •Gingival overgrowth
- •Necrotizing periodontal diseases
- •Pregnant or lactating
- •smokers or former-smokers
- •medication that can influence periodontal status or host response to periodontal therapy
- •periodontal therapy in the past 6 months from baseline
- •use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline
结局指标
主要结局
Changes in beta defensins 1, 2 and 3
时间窗: Baseline and 60 days
Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples
次要结局
- Changes in blood glycemic levels(Baseline and 60 days)
- Changes in percentage of diseased sites(Baseline and 60 days)
- Changes in periodontal pocket depth(Baseline and 60 days)
研究者
Fernando O Costa
Head of periodontology
Federal University of Minas Gerais
