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

Periodontitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01852240
• Other study ID #: Perio&ED
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 12, 2014
• Start date: May 2013

Study information

• Verified date: May 2014
• Source: Medical University of Vienna
• Contact: Florian Wimpissinger, MD
• Email: florianthomas.wimpissinger[@]wienkav.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Erectile Dysfunction
• hsCRP
• Periodontitis

Locations

Country	Name	City	State
Austria	Krankenanstalt Rudolfstiftung	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-questionnaire-value	IIEF-questionnaire-value - indicates severity of erectile dysfunction	1 day (cross-sectional, patients will not be followed up)	No
Primary	high sensitive C-reactive protein	blood value (mg/dl), assess correlation to IIEF-value	1 day (cross-sectional, patients will not be followed up)	No
Primary	severity of periodontal disease	mean pocket depth (mm), assess correlation to IIEF-value	1 day (cross-sectional, patients will not be followed up)	No