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临床试验/NCT03146975
NCT03146975已完成不适用

Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年3月2日最近更新:
适应症

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

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

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando O Costa

Head of periodontology

Federal University of Minas Gerais

研究点 (1)

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