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

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).

Study Overview

• Status: Unknown
• Conditions: Periodontitis; Erectile Dysfunction; hsCRP

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1030
    • Recruiting
    • Krankenanstalt Rudolfstiftung
    • Contact: Florian Wimpissinger, MD; Email: florianthomas.wimpissinger@wienkav.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-questionnaire-value	IIEF-questionnaire-value - indicates severity of erectile dysfunction	1 day (cross-sectional, patients will not be followed up)
high sensitive C-reactive protein	blood value (mg/dl), assess correlation to IIEF-value	1 day (cross-sectional, patients will not be followed up)
severity of periodontal disease	mean pocket depth (mm), assess correlation to IIEF-value	1 day (cross-sectional, patients will not be followed up)

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Periodontitis; Erectile Dysfunction
• Other Study ID Numbers: Perio&ED