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临床试验/NCT01852240
NCT01852240Unknown不适用

Periodontal Disease as a Risk Indicator for Erectile Dysfunction - A Cross-sectional Study on 100 Patients

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
IIEF-questionnaire-value

研究概览

简要总结

Background Increased levels of C reactive protein (CRP) can be found not only within individuals with periodontal diseases and those with atherosclerotic alterations but also have been proved in men with erectile dysfunction (ED). NO seems to be the key mediator in the endothelial-derived vasodilation and penile erection.

The incidence of ED increases in patients with diabetes, hypertonia, hypercholesteremia, cardiovascular diseases and renal failure. First evidence suggests that there is a relationship between periodontal disease and ED as well. Due to slow progression of chronic periodontal disease (0.3-0.5mm attachment loss/year) it can be assumed, that periodontal disease exists mainly before ED develops.

Specific Aims This cross-sectional study aims to assess the incidence of periodontal disease in male individuals with ED. A possible correlation between severity of periodontal disease, level of systemic hs-CRP and ED will be assessed. Additionally, further risk factors for endothelial dysfunction, such lipid values, will be determined and regarded in the analysis.

Hypothesis The investigators assume, that severity of ED correlates with severity of periodontal disease as well as with systemic involvement assessed by CRP-levels. In detail, the investigators hypothesize, that severity of ED (assessed by the questionnaire "International Index of Erectile Function") correlates with the mean probing depth and the level of systemic hs-CRP.

Material and Methods

  1. st appointment: In the present cross-sectional study 100 male patients with ED will be included. Patients who visit the urological department (Rudolfstiftung) for ED-treatment will be asked to participate. The erectile dysfunction will be assessed by means of a questionnaire (International Index of Erectile Function - IIEF-5). Urologic examination. The following blood parameters will be assessed: testosterone, prolactin, hs-CRP, tumor necrosis factor (TNF)-alpha, Interleukin-1, total cholesterol, LDL, HDL, HbA1c and fasting glucose.
  2. nd appointment: At the department of Oral Surgery (Bernhard Gottlieb School of Dentistry) the periodontal situation and the index of decayed-missing-filled permanent teeth (DMFT) index of the patients will be determined. A panoramic radiograph for assessment of alveolar bone loss and a periodontal status (probing depth, recession, bleeding- and plaque-indices) will be performed. The observer at the dental clinic will have no information on the severity of the ED (observer blinded).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

IIEF-questionnaire-value

时间窗: 1 day (cross-sectional, patients will not be followed up)

IIEF-questionnaire-value - indicates severity of erectile dysfunction

high sensitive C-reactive protein

时间窗: 1 day (cross-sectional, patients will not be followed up)

blood value (mg/dl), assess correlation to IIEF-value

severity of periodontal disease

时间窗: 1 day (cross-sectional, patients will not be followed up)

mean pocket depth (mm), assess correlation to IIEF-value

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Bertl

DMD, MSc

Medical University of Vienna

研究点 (1)

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