Erectile DysfunctionNCT01852240
Periodontal Disease as a Risk Indicator for Erectile Dysfunction - A Cross-sectional Study on 100 Patients
An observational study of Erectile Dysfunction and Periodontitis, run by Medical University of Vienna at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Periodontitis, hsCRP
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- May 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- male patients with ED defined by an IIEF-5 score of ≤ 21
- age between 18-45a
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Florian Wimpissinger, MD contact
Austria1 site, 1 recruiting
- Recruiting
Krankenanstalt Rudolfstiftung
Vienna, 1030
Florian Wimpissinger, MD, florianthomas.wimpissinger@wienkav.at
About this study
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.
Read more
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
- 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.
- 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
- Medical subject headings
- Erectile Dysfunction, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
IIEF-questionnaire-value
IIEF-questionnaire-value - indicates severity of erectile dysfunction
Measured: 1 day (cross-sectional, patients will not be followed up)
high sensitive C-reactive protein
blood value (mg/dl), assess correlation to IIEF-value
Measured: 1 day (cross-sectional, patients will not be followed up)
severity of periodontal disease
mean pocket depth (mm), assess correlation to IIEF-value
Measured: 1 day (cross-sectional, patients will not be followed up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bertl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852240
- Sponsor's protocol ID
- Perio&ED
- Status last verified
- May 2014
- First submitted
- 6 May 2013
- Last updated
- 14 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease as a Risk Indicator for Erectile Dysfunction - A Cross-sectional Study on 100 Patients
- ClinicalTrials.gov ID
- NCT01852240
- Acronym / sponsor ID
- Perio&ED
- Conditions
- Erectile Dysfunction, Periodontitis, hsCRP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- male patients with ED defined by an IIEF-5 score of ≤ 21
- age between 18-45a
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IIEF-questionnaire-value
Time frame: 1 day (cross-sectional, patients will not be followed up)
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)
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)
mean pocket depth (mm), assess correlation to IIEF-value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
Related trials for Erectile Dysfunction
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Wimpissinger, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Periodontitis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Wimpissinger, MD (florianthomas.wimpissinger@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-questionnaire-value (time frame: 1 day (cross-sectional, patients will not be followed up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.