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

NCT01852240 | Unknown

• 1 other identifier: Perio&ED
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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).

Conditions

Erectile Dysfunction; Periodontitis; hsCRP

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

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 Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Krankenanstalt Rudolfstiftung

Vienna, 1030, Austria

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Periodontitis

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Florian Wimpissinger, MD

CONTACT

florianthomas.wimpissinger@wienkav.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, MSc

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 13, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

AU (1)