Periodontitis Clinical Trial
NCT number | NCT01852240 |
Other study ID # | Perio&ED |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | May 6, 2013 |
Last updated | May 12, 2014 |
Start date | May 2013 |
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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Austria | Krankenanstalt Rudolfstiftung | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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 |
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