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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Kristina Bertl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01852240
First received: May 6, 2013
Last updated: May 12, 2014
Last verified: May 2014

May 6, 2013
May 12, 2014
May 2013
December 2015   (final data collection date for primary outcome measure)
  • IIEF-questionnaire-value [ Time Frame: 1 day (cross-sectional, patients will not be followed up) ] [ Designated as safety issue: No ]
    IIEF-questionnaire-value - indicates severity of erectile dysfunction
  • high sensitive C-reactive protein [ Time Frame: 1 day (cross-sectional, patients will not be followed up) ] [ Designated as safety issue: No ]
    blood value (mg/dl), assess correlation to IIEF-value
  • severity of periodontal disease [ Time Frame: 1 day (cross-sectional, patients will not be followed up) ] [ Designated as safety issue: No ]
    mean pocket depth (mm), assess correlation to IIEF-value
Same as current
Complete list of historical versions of study NCT01852240 on ClinicalTrials.gov Archive Site
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Periodontal Disease as a Risk Indicator for Erectile Dysfunction - A Cross-sectional Study on 100 Patients
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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).
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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

  • Erectile Dysfunction
  • Periodontitis
  • hsCRP
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erectile dysfunction

Inclusion criteria:

  • male patients with ED defined by an IIEF-5 score of ≤ 21
  • age between 18-45a

Exclusion criteria:

  • systemic diseases (e.g. diabetes mellitus, heart disease, hypertension, neurological disorders etc.)
  • pure psychogenic (non-organic) ED with good spontaneous / nightly erections
  • periodontal treatment within the last 3 months
  • antibiotic intake within the last 3 months
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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December 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  • male patients with ED defined by an IIEF-5 score of ≤ 21
  • age between 18-45a

Exclusion criteria:

  • systemic diseases (e.g. diabetes mellitus, heart disease, hypertension, neurological disorders etc.)
  • pure psychogenic (non-organic) ED with good spontaneous / nightly erections
  • periodontal treatment within the last 3 months
  • antibiotic intake within the last 3 months
Male
18 Years to 45 Years
Yes
Contact: Florian Wimpissinger, MD florianthomas.wimpissinger@wienkav.at
Austria
 
NCT01852240
Perio&ED
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Kristina Bertl, Medical University of Vienna
Medical University of Vienna
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Medical University of Vienna
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP