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
  Purpose

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).

Condition
Erectile Dysfunction
Periodontitis
hsCRP

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852240

Contacts
Contact: Florian Wimpissinger, MD florianthomas.wimpissinger@wienkav.at

Locations
Austria
Krankenanstalt Rudolfstiftung Recruiting
Vienna, Austria, 1030
Contact: Florian Wimpissinger, MD       florianthomas.wimpissinger@wienkav.at   
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Kristina Bertl, DMD, MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01852240     History of Changes
Other Study ID Numbers: Perio&ED
Study First Received: May 6, 2013
Last Updated: May 12, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Erectile Dysfunction
Periodontitis
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014